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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 K870431
Device Name GAUZE, ABSORBENT, IODOFORM IMPREGNATED
Applicant
Steridyne Laboratories, Inc.
Washington Sq.
1050 Connecticut Ave. NW
Washington,  DC  20036
Applicant Contact PETER S REICHERTZ
Correspondent
Steridyne Laboratories, Inc.
Washington Sq.
1050 Connecticut Ave. NW
Washington,  DC  20036
Correspondent Contact PETER S REICHERTZ
Classification Product Code
FRO  
Date Received02/03/1987
Decision Date 02/26/1987
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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