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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, Occlusive
510(k) Number K881426
Device Name PAN-PRA AID SELF-ADHE. COLLO. COATED BANDAGE
Applicant
Laboratoire Pan-Pra
2125, Boul. Industriel
Chambly, Que.
Canada,  CA J3L 4C5
Applicant Contact DENIS BERTRAND
Correspondent
Laboratoire Pan-Pra
2125, Boul. Industriel
Chambly, Que.
Canada,  CA J3L 4C5
Correspondent Contact DENIS BERTRAND
Regulation Number878.4020
Classification Product Code
NAD  
Date Received04/05/1988
Decision Date 11/10/1988
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General & Plastic Surgery
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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