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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name retractor
510(k) Number K852415
Device Name TITANIUM PROBES
Applicant
LASER, INC.
P.O. BOX 358
TOMBALL,  TX  77375
Applicant Contact WILLIAM PRZYBY
Correspondent
LASER, INC.
P.O. BOX 358
TOMBALL,  TX  77375
Correspondent Contact WILLIAM PRZYBY
Regulation Number878.4800
Classification Product Code
GAD  
Date Received06/07/1985
Decision Date 08/02/1985
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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