DISPOSABLE INSUFFLATION TUBING

Laparoscope, General & Plastic Surgery

LASER, INC.

The following data is part of a premarket notification filed by Laser, Inc. with the FDA for Disposable Insufflation Tubing.

Pre-market Notification Details

Device IDK932045
510k NumberK932045
Device Name:DISPOSABLE INSUFFLATION TUBING
ClassificationLaparoscope, General & Plastic Surgery
Applicant LASER, INC. P.O. BOX 358 Tomball,  TX  77375
ContactKeith Przybyla
CorrespondentKeith Przybyla
LASER, INC. P.O. BOX 358 Tomball,  TX  77375
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-04-27
Decision Date1993-09-23

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