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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 K945144
Device Name SPONGE COUNT
Applicant
Michael Fischer Assoc.
1248 Pine St.
Winnetka,  IL  60093
Applicant Contact MICHAEL FISCHER
Correspondent
Michael Fischer Assoc.
1248 Pine St.
Winnetka,  IL  60093
Correspondent Contact MICHAEL FISCHER
Regulation Number880.2740
Classification Product Code
LWH  
Date Received10/20/1994
Decision Date 01/12/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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