MODEL 20-C WITH AN SA-20A/U OPT. ATTACH. HEMORRHO.

Laser For Gastro-urology Use

DIRECTED ENERGY, INC.

The following data is part of a premarket notification filed by Directed Energy, Inc. with the FDA for Model 20-c With An Sa-20a/u Opt. Attach. Hemorrho..

Pre-market Notification Details

Device IDK871032
510k NumberK871032
Device Name:MODEL 20-C WITH AN SA-20A/U OPT. ATTACH. HEMORRHO.
ClassificationLaser For Gastro-urology Use
Applicant DIRECTED ENERGY, INC. 11661 SAN VICENTE BLVD. SUITE 203 Los Angeles,  CA  90049
ContactEdward Johansen
CorrespondentEdward Johansen
DIRECTED ENERGY, INC. 11661 SAN VICENTE BLVD. SUITE 203 Los Angeles,  CA  90049
Product CodeLNK  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-03-16
Decision Date1987-05-18

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