KEVTEK(TM) LASER DRAPE/ORGAN PROTECTOR/EYE SHIELD

Curette, Surgical, General Use

KEVTEK MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Kevtek Medical Products, Inc. with the FDA for Kevtek(tm) Laser Drape/organ Protector/eye Shield.

Pre-market Notification Details

Device IDK902000
510k NumberK902000
Device Name:KEVTEK(TM) LASER DRAPE/ORGAN PROTECTOR/EYE SHIELD
ClassificationCurette, Surgical, General Use
Applicant KEVTEK MEDICAL PRODUCTS, INC. P.O. BOX 580644 Houston,  TX  77258
ContactWeinberg, Phd
CorrespondentWeinberg, Phd
KEVTEK MEDICAL PRODUCTS, INC. P.O. BOX 580644 Houston,  TX  77258
Product CodeFZS  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-05-02
Decision Date1990-08-21

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