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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 K920874
Device Name PROLONGED OCCLUSION DRESSING II
Applicant
Ferndal Laboratories
1575 Eye St. NW
Washington,  DC  20005
Applicant Contact DONALD R STONE
Correspondent
Ferndal Laboratories
1575 Eye St. NW
Washington,  DC  20005
Correspondent Contact DONALD R STONE
Classification Product Code
FRO  
Date Received02/26/1992
Decision Date 06/16/1992
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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