CUSTOM INSTRUMENT DRAPE

Drape, Microscope, Ophthalmic

LIFESTREAM INT'L, INC.

The following data is part of a premarket notification filed by Lifestream Int'l, Inc. with the FDA for Custom Instrument Drape.

Pre-market Notification Details

Device IDK843890
510k NumberK843890
Device Name:CUSTOM INSTRUMENT DRAPE
ClassificationDrape, Microscope, Ophthalmic
Applicant LIFESTREAM INT'L, INC. 525 JULIE RIVERS DR. SUITE 100 Sugarland,  TX  77478
ContactRick Wilborn
CorrespondentRick Wilborn
LIFESTREAM INT'L, INC. 525 JULIE RIVERS DR. SUITE 100 Sugarland,  TX  77478
Product CodeHMW  
CFR Regulation Number878.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-10-02
Decision Date1984-10-26

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