UNIVERSAL VIDEO/LASER ARM DRAPE

Drape, Surgical

HYDRO-MED PRODUCTS, INC.

The following data is part of a premarket notification filed by Hydro-med Products, Inc. with the FDA for Universal Video/laser Arm Drape.

Pre-market Notification Details

Device IDK934630
510k NumberK934630
Device Name:UNIVERSAL VIDEO/LASER ARM DRAPE
ClassificationDrape, Surgical
Applicant HYDRO-MED PRODUCTS, INC. 2930 LADYBIRD LN. Dallas,  TX  75220
ContactBonnie Beasley
CorrespondentBonnie Beasley
HYDRO-MED PRODUCTS, INC. 2930 LADYBIRD LN. Dallas,  TX  75220
Product CodeKKX  
CFR Regulation Number878.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-09-24
Decision Date1994-10-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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10850301007669 K934630 000
10850301007652 K934630 000
10850301007645 K934630 000
10855495007341 K934630 000

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