LASER-35

Powered Laser Surgical Instrument

ENDO TECHNIC CORP.

The following data is part of a premarket notification filed by Endo Technic Corp. with the FDA for Laser-35.

Pre-market Notification Details

Device IDK910200
510k NumberK910200
Device Name:LASER-35
ClassificationPowered Laser Surgical Instrument
Applicant ENDO TECHNIC CORP. 3002 DOW AVENUE, STE 114 Tustin,  CA  92680
ContactPhilippe C Levy
CorrespondentPhilippe C Levy
ENDO TECHNIC CORP. 3002 DOW AVENUE, STE 114 Tustin,  CA  92680
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-01-15
Decision Date1991-05-09

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