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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 K042555
Device Name SURGICHIP TAG SURGICAL MARKER
Applicant
SURGICHIP, INC.
4398 HICKORY DRIVE
PALM GARDENS,  FL  33418
Applicant Contact BRUCE WAXMAN
Correspondent
SURGICHIP, INC.
4398 HICKORY DRIVE
PALM GARDENS,  FL  33418
Correspondent Contact BRUCE WAXMAN
Regulation Number878.4660
Classification Product Code
FZZ  
Date Received09/20/2004
Decision Date 11/09/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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