DISPOSABLE LASER PROTECTIVE DRAPE FOR CO2 LASER

Drape, Surgical

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 Protective Drape For Co2 Laser.

Pre-market Notification Details

Device IDK871068
510k NumberK871068
Device Name:DISPOSABLE LASER PROTECTIVE DRAPE FOR CO2 LASER
ClassificationDrape, Surgical
Applicant LIFESTREAM INT'L, INC. 10940 S. WILCREST Houston,  TX  77099
ContactRoger Mogill
CorrespondentRoger Mogill
LIFESTREAM INT'L, INC. 10940 S. WILCREST Houston,  TX  77099
Product CodeKKX  
CFR Regulation Number878.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-03-18
Decision Date1987-05-28

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.