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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Surgical Instrument, Disposable
510(k) Number K011514
Device Name INSTRUMENTS FOR ONE TIME USE - DISPOSABLE
Applicant
Kencap , Ltd.
247 Margaret King Ave.
Ringwood,  NJ  07456
Applicant Contact MARTY DELIN
Correspondent
Kencap , Ltd.
247 Margaret King Ave.
Ringwood,  NJ  07456
Correspondent Contact MARTY DELIN
Regulation Number878.4800
Classification Product Code
KDD  
Date Received05/17/2001
Decision Date 08/13/2001
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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