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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, reprocessed
510(k) Number K012644
Device Name REPROCESSED TROCARS AND CANNULAS
Applicant
SURGICAL INSTRUMENTS SERVICE AND SAVINGS, INC.
3636 E COLUMBINE DR.
PHOENIX,  AZ  85032 -5655
Applicant Contact ROBERT S MCQUATE
Correspondent
SURGICAL INSTRUMENTS SERVICE AND SAVINGS, INC.
3636 E COLUMBINE DR.
PHOENIX,  AZ  85032 -5655
Correspondent Contact ROBERT S MCQUATE
Regulation Number876.1500
Classification Product Code
NLM  
Date Received08/13/2001
Decision Date 07/29/2002
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
Recalls CDRH Recalls
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