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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tape, Measuring, Rulers And Calipers
510(k) Number K840651
Device Name MOLE-MARKER
Applicant
NOTATION SYSTEMS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
NOTATION SYSTEMS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4800
Classification Product Code
FTY  
Date Received02/15/1984
Decision Date 03/12/1984
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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