DORNIER MEDILA H

Powered Laser Surgical Instrument

DORNIER MEDTECH AMERICA, INC.

The following data is part of a premarket notification filed by Dornier Medtech America, Inc. with the FDA for Dornier Medila H.

Pre-market Notification Details

Device IDK983963
510k NumberK983963
Device Name:DORNIER MEDILA H
ClassificationPowered Laser Surgical Instrument
Applicant DORNIER MEDTECH AMERICA, INC. 1155 ROBERTS BLVD. Kennesaw,  GA  30144
ContactCarol Wernecke
CorrespondentCarol Wernecke
DORNIER MEDTECH AMERICA, INC. 1155 ROBERTS BLVD. Kennesaw,  GA  30144
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-11-06
Decision Date1998-11-25
Summary:summary

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