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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Operating Room Accessories Table Tray
510(k) Number K926225
Device Name SPONGE COUNTER
Applicant
American Medical Manufacturer, Inc.
21026 Osborne St.
Canoga Park,  CA  91304
Applicant Contact MIKE HOFTMAN
Correspondent
American Medical Manufacturer, Inc.
21026 Osborne St.
Canoga Park,  CA  91304
Correspondent Contact MIKE HOFTMAN
Regulation Number878.4950
Classification Product Code
FWZ  
Date Received12/10/1992
Decision Date 03/05/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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