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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name curette, surgical, general use
510(k) Number K902000
Device Name KEVTEK(TM) LASER DRAPE/ORGAN PROTECTOR/EYE SHIELD
Applicant
KEVTEK MEDICAL PRODUCTS, INC.
P.O. BOX 580644
HOUSTON,  TX  77258
Applicant Contact WEINBERG, PHD
Correspondent
KEVTEK MEDICAL PRODUCTS, INC.
P.O. BOX 580644
HOUSTON,  TX  77258
Correspondent Contact WEINBERG, PHD
Regulation Number878.4800
Classification Product Code
FZS  
Date Received05/02/1990
Decision Date 08/21/1990
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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