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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blade, Scalpel
510(k) Number K821737
Device Name DISP. MICROSURGICAL KNIVES
Applicant
Coburn Optical Ind., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Coburn Optical Ind., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number878.4800
Classification Product Code
GES  
Date Received06/14/1982
Decision Date 07/02/1982
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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