PEGASUS W/ACCESSORIES FOR GENERAL SURGERY

Powered Laser Surgical Instrument

PFIZER LASER SYSTEMS

The following data is part of a premarket notification filed by Pfizer Laser Systems with the FDA for Pegasus W/accessories For General Surgery.

Pre-market Notification Details

Device IDK902946
510k NumberK902946
Device Name:PEGASUS W/ACCESSORIES FOR GENERAL SURGERY
ClassificationPowered Laser Surgical Instrument
Applicant PFIZER LASER SYSTEMS 3 MORGAN Irvine,  CA  92718
ContactCozean, Phd
CorrespondentCozean, Phd
PFIZER LASER SYSTEMS 3 MORGAN Irvine,  CA  92718
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-07-05
Decision Date1990-10-02

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