510(k) K003229

Device

BIOPATCH ANTIMICROBIAL DRESSING

Applicant

INTEGRA LIFESCIENCES CORP.

510(k) number

K003229

Product code

FRO  

Decision

Substantially Equivalent (SESE)

Decision date

2001-10-26

Date received

2000-10-10

Regulation

510(k) Premarket Notification

Classification name

Dressing, Wound, Drug

Medical specialty

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Review panel

General & Plastic Surgery

Device class

U

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No