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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 K974348
Device Name ALGOPLAQUE FILM EXTRA THIN HYDROCOLLOID DRESSING
Applicant
Laboratoires Urgo S.A.
7527 Westmoreland Ave.
St Louis,  MO  63105
Applicant Contact EVAN DICK
Correspondent
Laboratoires Urgo S.A.
7527 Westmoreland Ave.
St Louis,  MO  63105
Correspondent Contact EVAN DICK
Classification Product Code
FRO  
Date Received11/19/1997
Decision Date 02/13/1998
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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