COHERENT TISSUE MORCELLATOR KIT AND ACCESSORIES

Laparoscope, General & Plastic Surgery

LUMENIS, INC.

The following data is part of a premarket notification filed by Lumenis, Inc. with the FDA for Coherent Tissue Morcellator Kit And Accessories.

Pre-market Notification Details

Device IDK980079
510k NumberK980079
Device Name:COHERENT TISSUE MORCELLATOR KIT AND ACCESSORIES
ClassificationLaparoscope, General & Plastic Surgery
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 CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-01-09
Decision Date1998-04-09
Summary:summary

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