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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 K912730
Device Name ROCKET SURGICAL SKIN MARKING PEN
Applicant
WEST TEXAS LIGHTHOUSE FOR THE BLIND
2001 AUSTIN ST.
SAN ANGELO,  TX  76903
Applicant Contact RONALD J BEARD
Correspondent
WEST TEXAS LIGHTHOUSE FOR THE BLIND
2001 AUSTIN ST.
SAN ANGELO,  TX  76903
Correspondent Contact RONALD J BEARD
Regulation Number878.4660
Classification Product Code
FZZ  
Date Received06/20/1991
Decision Date 11/07/1991
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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