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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dressing, wound, drug
510(k) Number K990086
Device Name HELIDERM COLLAGEN WOUND DRESSINGS 0.5 GRAM AND 1.0 GRAM
Applicant
INTEGRA LIFESCIENCES CORP.
105 MORGAN LANE
PLAINSBORO,  NJ  08536
Applicant Contact JUDITH E O'GRADY
Correspondent
INTEGRA LIFESCIENCES CORP.
105 MORGAN LANE
PLAINSBORO,  NJ  08536
Correspondent Contact JUDITH E O'GRADY
Classification Product Code
FRO  
Date Received01/11/1999
Decision Date 03/31/1999
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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