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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 K891998
Device Name BANDAGE, MUSLIN, COMPRESSED, CAMOUFLAGED, 37X37X52
Applicant
Elwyn Industries
5001 Lancaster Ave.
Philadelphia,  PA  19131
Applicant Contact TOM WALSH
Correspondent
Elwyn Industries
5001 Lancaster Ave.
Philadelphia,  PA  19131
Correspondent Contact TOM WALSH
Regulation Number878.4020
Classification Product Code
NAD  
Date Received03/28/1989
Decision Date 06/05/1989
Decision Substantially Equivalent (SESE)
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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