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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K964123
Device Name REUSABLE TROCAR WITH SLEEVE (COMMON)
Applicant
Pilling Weck Group
Tall Pines Park
Jeffrey,  NH  03452
Applicant Contact KARENANN J BROZOWSKI
Correspondent
Pilling Weck Group
Tall Pines Park
Jeffrey,  NH  03452
Correspondent Contact KARENANN J BROZOWSKI
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received10/15/1996
Decision Date 12/12/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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