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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrosurgical, cutting & coagulation & accessories
510(k) Number K031869
Device Name SISS INC. (D.B.A. MEDISISS) REPROCESSED ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES
Applicant
SURGICAL INSTRUMENTS SERVICE AND SAVINGS, INC.
723 CURTIS CT, SUITE A
SISTERS,  OR  97759
Applicant Contact MARY ANN BARKER
Correspondent
UNDERWRITERS LABORATORIES, INC.
1655 SCOTT BLVD.
SANTA CLARA,  CA  95050
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/17/2003
Decision Date 12/24/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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