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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Forceps, General & Plastic Surgery
510(k) Number K884181
Device Name MANUAL SURGICAL INSTRUMENTS (SEVERAL MODELS)
Applicant
Sales & Marketing Assoc.
40 Industrial Rd.
Berkley Heights,  NJ  07922
Applicant Contact DAVID MILLER
Correspondent
Sales & Marketing Assoc.
40 Industrial Rd.
Berkley Heights,  NJ  07922
Correspondent Contact DAVID MILLER
Regulation Number878.4800
Classification Product Code
GEN  
Date Received10/03/1988
Decision Date 11/10/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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