SL-100 ND:YAG LASER FOR GASTROINTESTINAL BLEEDING

Laser For Gastro-urology Use

MEDICAL ENERGY, INC.

The following data is part of a premarket notification filed by Medical Energy, Inc. with the FDA for Sl-100 Nd:yag Laser For Gastrointestinal Bleeding.

Pre-market Notification Details

Device IDK871515
510k NumberK871515
Device Name:SL-100 ND:YAG LASER FOR GASTROINTESTINAL BLEEDING
ClassificationLaser For Gastro-urology Use
Applicant MEDICAL ENERGY, INC. 8518 PUNTA LORA Pensacola,  FL  32514
ContactDavid P Lewing
CorrespondentDavid P Lewing
MEDICAL ENERGY, INC. 8518 PUNTA LORA Pensacola,  FL  32514
Product CodeLNK  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-04-20
Decision Date1987-07-09

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