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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
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