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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Grasping/Cutting Instrument, Non-Powered
510(k) Number K894986
Device Name 3-RING HANDLE, GRASP FORCEPS, LOOP RETRIE., BASKET
Applicant
North American Sterilization & Packaging Co.
15 White Lake Rd.
P.O. Box 923
Sparta,  NJ  07871
Applicant Contact CHARLES E MEISCH
Correspondent
North American Sterilization & Packaging Co.
15 White Lake Rd.
P.O. Box 923
Sparta,  NJ  07871
Correspondent Contact CHARLES E MEISCH
Regulation Number876.1500
Classification Product Code
OCZ  
Subsequent Product Code
NQU  
Date Received08/08/1989
Decision Date 12/01/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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