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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 K965176
Device Name PILLING WECK 2 PIECE TAKE-APART INSTRUMENTS
Applicant
PILLING WECK GROUP
TALL PINES PARK
JAFFREY,  NH  03452
Applicant Contact KARENANN J BROZOWSKI
Correspondent
PILLING WECK GROUP
TALL PINES PARK
JAFFREY,  NH  03452
Correspondent Contact KARENANN J BROZOWSKI
Regulation Number876.1500
Classification Product Code
OCZ  
Date Received12/24/1996
Decision Date 03/04/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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