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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name marker, skin
510(k) Number K761323
Device Name SURGICAL MARKING PEN
Applicant
RICHARD-ALLAN MEDICAL IND., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
RICHARD-ALLAN MEDICAL IND., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4660
Classification Product Code
FZZ  
Date Received12/27/1976
Decision Date 01/12/1977
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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