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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 K914759
Device Name BLOOM TRANSPARENT STENCIL
Applicant
FRECKLES PUBLICATIONS, INC.
C/O COFFEE - NOVAK, ATTORNEYS
POST OFFICE BOX 3726
LUBBOCK,  TX  79452
Applicant Contact NEAL BURT
Correspondent
FRECKLES PUBLICATIONS, INC.
C/O COFFEE - NOVAK, ATTORNEYS
POST OFFICE BOX 3726
LUBBOCK,  TX  79452
Correspondent Contact NEAL BURT
Regulation Number878.4660
Classification Product Code
FZZ  
Date Received10/22/1991
Decision Date 04/21/1992
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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