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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 K033842
Device Name NUBERT, ALBERT AND HUBERT IMPERVIOUS BAGS FOR ENDOSCOPIC RETRIEVAL OF TISSUE
Applicant
Vernon-Carus Limited
P.O. Box 2608
Morgan Hill,  CA  95038
Applicant Contact C. ROBERT PAYNE, JR., P.E.
Correspondent
Vernon-Carus Limited
P.O. Box 2608
Morgan Hill,  CA  95038
Correspondent Contact C. ROBERT PAYNE, JR., P.E.
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received12/10/2003
Decision Date 03/04/2004
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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