ENCOLL CORP.

Address:4576 Enterprise Street,Fremont,CA,94538,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

Dressing, Wound, Collagen (KGN) (5)

Premarket Exempt

Clear

HELICOLL - 10860000744406 Catalog Number : HC2x2

Device Description : HELICOLL is a biological, sterile, reconstituted bovine Type-I Collagen Sheet of

Device Class : U

Duns Number: 962858049

Premarket Exempt : No

Product Code : KGN

Prescription Use : Yes

Device Count : 5

HELICOLL - 10860000744413 Catalog Number : HC2x4

Device Description : HELICOLL is a biological, sterile, reconstituted bovine Type-I Collagen Sheet of

Device Class : U

Duns Number: 962858049

Premarket Exempt : No

Product Code : KGN

Prescription Use : Yes

Device Count : 5

HELICOLL - 10860000744420 Catalog Number : HC4x4

Device Description : HELICOLL is a biological, sterile, reconstituted bovine Type-I Collagen Sheet of

Device Class : U

Duns Number: 962858049

Premarket Exempt : No

Product Code : KGN

Prescription Use : Yes

Device Count : 5

HELICOLL - 10860000744437 Catalog Number : HC8x8

Device Description : HELICOLL is a biological, sterile, reconstituted bovine Type-I Collagen Sheet of

Device Class : U

Duns Number: 962858049

Premarket Exempt : No

Product Code : KGN

Prescription Use : Yes

Device Count : 5

HELICOLL - 10860000744444 Catalog Number : HC0.5dia

Device Description : HELICOLL is a biological, sterile, reconstituted bovine Type-I Collagen Sheet of

Device Class : U

Duns Number: 962858049

Premarket Exempt : No

Product Code : KGN

Prescription Use : Yes

Device Count : 2

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