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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name scalpel, one-piece
510(k) Number K800177
Device Name I.M. BLADES
Applicant
INSTRUMENT MAKAR, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
INSTRUMENT MAKAR, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4800
Classification Product Code
GDX  
Date Received01/28/1980
Decision Date 02/11/1980
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
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