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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name forceps, biopsy, electric, reprocessed
510(k) Number K024011
Device Name SISS REPROCESSED HOT BIOPSY FORCEPS, LAPAROSCOPIC, ENDOSCOPIC AND ELECTROSURGICAL SURGICAL INSTRUMENTS AND ACCESSORIES
Applicant
SURGICAL INSTRUMENTS SERVICE AND SAVINGS, INC.
723 CURTIS CT; PO BOX 2060
SISTERS,  OR  97759
Applicant Contact MARY ANN BARKER
Correspondent
UNDERWRITERS LABORATORIES, INC.
2600 NW LAKE RD.
CAMAS,  WA  98607 -9526
Correspondent Contact ROBERT M BOONSTRA
Regulation Number876.4300
Classification Product Code
NLU  
Date Received12/04/2002
Decision Date 12/19/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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