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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scale, Sponge, Surgical, Electrically-Powered
510(k) Number K964181
Device Name SPONGETRAC
Applicant
Surgitrac Corp.
555 Thirteenth St. NW
Washington,  DC  20004
Applicant Contact JONATHAN S KAHAN
Correspondent
Surgitrac Corp.
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact JONATHAN S KAHAN
Regulation Number880.2740
Classification Product Code
MRL  
Date Received10/18/1996
Decision Date 02/26/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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