COHERENT SLIMLINE SINGLE LUMEN ASPIRATION NEEDLE KIT

Powered Laser Surgical Instrument

LUMENIS, INC.

The following data is part of a premarket notification filed by Lumenis, Inc. with the FDA for Coherent Slimline Single Lumen Aspiration Needle Kit.

Pre-market Notification Details

Device IDK960413
510k NumberK960413
Device Name:COHERENT SLIMLINE SINGLE LUMEN ASPIRATION NEEDLE KIT
ClassificationPowered Laser Surgical Instrument
Applicant LUMENIS, INC. 3270 WEST BAYSHORE RD. POST OFFICE BOX 10122 Palo Alto,  CA  94303 -0810
ContactAnne Worden
CorrespondentAnne Worden
LUMENIS, INC. 3270 WEST BAYSHORE RD. POST OFFICE BOX 10122 Palo Alto,  CA  94303 -0810
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-01-29
Decision Date1996-04-04
Summary:summary

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