Enova Illumination, Inc.

Enova Illumination, Inc.

Address:6305 Sandburg Rd.,Minneapolis,MN,55427,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Headlamp, Operating, Battery-Operated (HPP) (10)

Premarket Exempt

Yes

Clear

NA - 00850025993005 Catalog Number : 5460-700-020

Device Description : PP4 Power Pack

Device Class : 1

Duns Number: 080805136

Premarket Exempt : Yes

Product Code : HPP

Prescription Use : No

Device Count : 1

NA - 00850025993050 Catalog Number : 5460-700-032

Device Description : Black Single Ratchet Headband and attached bracket

Device Class : 1

Duns Number: 080805136

Premarket Exempt : Yes

Product Code : HPP

Prescription Use : No

Device Count : 1

NA - 00850025993067 Catalog Number : 5460-700-031

Device Description : Black Double Ratchet Headband with Occipital Pad Support and attached bracket

Device Class : 1

Duns Number: 080805136

Premarket Exempt : Yes

Product Code : HPP

Prescription Use : No

Device Count : 1

NA - 00850025993074 Catalog Number : 5460-700-030

Device Description : Quantum Occipital Mesh Replacement

Device Class : 1

Duns Number: 080805136

Premarket Exempt : Yes

Product Code : HPP

Prescription Use : No

Device Count : 1

NA - 00850025993081 Catalog Number : 5460-700-027

Device Description : Quantum Deluxe Comfort Pad Set

Device Class : 1

Duns Number: 080805136

Premarket Exempt : Yes

Product Code : HPP

Prescription Use : No

Device Count : 1

NA - 00850025993098 Catalog Number : 5460-700-029

Device Description : Composite Carrying Case

Device Class : 1

Duns Number: 080805136

Premarket Exempt : Yes

Product Code : HPP

Prescription Use : No

Device Count : 1

NA - 00850025993104 Catalog Number : 5460-700-028

Device Description : Quasar Standard Comfort Pad Set

Device Class : 1

Duns Number: 080805136

Premarket Exempt : Yes

Product Code : HPP

Prescription Use : No

Device Count : 1

NA - 00850025993111 Catalog Number : 5460-700-026

Device Description : Quantum Occipital Comfort Pad

Device Class : 1

Duns Number: 080805136

Premarket Exempt : Yes

Product Code : HPP

Prescription Use : No

Device Count : 1

NA - 00850025993128 Catalog Number : 5460-700-025

Device Description : PP4 Battery Belt

Device Class : 1

Duns Number: 080805136

Premarket Exempt : Yes

Product Code : HPP

Prescription Use : No

Device Count : 1

NA - 00850025993135 Catalog Number : 5460-700-022

Device Description : NA C-13 Power Cord

Device Class : 1

Duns Number: 080805136

Premarket Exempt : Yes

Product Code : HPP

Prescription Use : No

Device Count : 1

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