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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cutter, Surgical
510(k) Number K790684
Device Name COLOR CODING OF SURGICAL INSTRUMENTS
Applicant
Sara Dan, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Sara Dan, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number878.4800
Classification Product Code
FZT  
Date Received04/11/1979
Decision Date 05/18/1979
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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