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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 And Burn, Occlusive
510(k) Number K970518
Device Name ALGOPLAQUE HYDROCOLLOID DRESSING
Applicant
Laboratoires Urgo S.A.
7527 Westmoreland Ave.
St Louis,  MO  63105
Applicant Contact EVAN DICK, PH.D.
Correspondent
Laboratoires Urgo S.A.
7527 Westmoreland Ave.
St Louis,  MO  63105
Correspondent Contact EVAN DICK, PH.D.
Classification Product Code
MGP  
Date Received02/11/1997
Decision Date 03/21/1997
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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