DISPOSABLE LASER SPONGE SURGIMEDICS, 902001-000

Gauze/sponge, Internal, X-ray Detectable

LIFESTREAM INT'L, INC.

The following data is part of a premarket notification filed by Lifestream Int'l, Inc. with the FDA for Disposable Laser Sponge Surgimedics, 902001-000.

Pre-market Notification Details

Device IDK863089
510k NumberK863089
Device Name:DISPOSABLE LASER SPONGE SURGIMEDICS, 902001-000
ClassificationGauze/sponge, Internal, X-ray Detectable
Applicant LIFESTREAM INT'L, INC. 525 JULIE RIVERS DR. SUITE 100 Sugarland,  TX  77478
ContactMike Barbour
CorrespondentMike Barbour
LIFESTREAM INT'L, INC. 525 JULIE RIVERS DR. SUITE 100 Sugarland,  TX  77478
Product CodeGDY  
CFR Regulation Number878.4450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-08-13
Decision Date1986-10-14

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