A.M.A. PLASTICS

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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

Device, Anti-Snoring (LRK) (6)

Premarket Exempt

Clear

Zyppah - 00866868000305 Catalog Number : ZCA-100-03

Device Description : Hybrid oral appliance, camouflage version

Device Class : 2

Duns Number: 064454531

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

Zyppah - 00866868000312 Catalog Number : ZCA-100-01

Device Description : Hybrid oral appliance, grey / green version

Device Class : 2

Duns Number: 064454531

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

Zyppah - 00866868000329 Catalog Number : ZCA-100-02

Device Description : Hybrid oral appliance, pink version

Device Class : 2

Duns Number: 064454531

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

Zyppah - 00866868000336 Catalog Number : ZCA-100-05

Device Description : Hybrid oral appliance, marbled pink / pink / white version

Device Class : 2

Duns Number: 064454531

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

Zyppah - 00866868000343 Catalog Number : ZCA-100-04

Device Description : Hybrid oral appliance, red / white / blue version

Device Class : 2

Duns Number: 064454531

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

Zyppah - 00866868000381 Catalog Number : ZHA-100-01

Device Class : 2

Duns Number: 064454531

Premarket Exempt : No

Product Code : LRK

Prescription Use : No

Device Count : 1

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