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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name counter, sponge, surgical
510(k) Number K060076
Device Name SURGICOUNT SAFETY-SPONGE SYSTEM
Applicant
SURGICOUNT MEDICAL
5582 CHALON ROAD
YORBA LINDA,  CA  92886
Applicant Contact SHARON ROCKWELL
Correspondent
SURGICOUNT MEDICAL
5582 CHALON ROAD
YORBA LINDA,  CA  92886
Correspondent Contact SHARON ROCKWELL
Regulation Number880.2740
Classification Product Code
LWH  
Subsequent Product Code
GDY  
Date Received01/10/2006
Decision Date 03/14/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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