UROTEK RE-USABLE FIBEROPTIC CABLE

Powered Laser Surgical Instrument

ENERGY LIFE SYSTEMS CORP.

The following data is part of a premarket notification filed by Energy Life Systems Corp. with the FDA for Urotek Re-usable Fiberoptic Cable.

Pre-market Notification Details

Device IDK951933
510k NumberK951933
Device Name:UROTEK RE-USABLE FIBEROPTIC CABLE
ClassificationPowered Laser Surgical Instrument
Applicant ENERGY LIFE SYSTEMS CORP. 3303 HARBOR BLVD., UNIT D-13 Costa Mesa,  CA  92626
ContactHany Hussein
CorrespondentHany Hussein
ENERGY LIFE SYSTEMS CORP. 3303 HARBOR BLVD., UNIT D-13 Costa Mesa,  CA  92626
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-04-25
Decision Date1995-05-26

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