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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 K870430
Device Name PAD, PETROLATUM & BISMUTH TRIBROMOPHENATE IMPREG.
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 04/13/1987
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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