LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEM

Laparoscope, General & Plastic Surgery

LUMENIS, INC.

The following data is part of a premarket notification filed by Lumenis, Inc. with the FDA for Lumenis Versacut Tissue Morcellator System.

Pre-market Notification Details

Device IDK050639
510k NumberK050639
Device Name:LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEM
ClassificationLaparoscope, General & Plastic Surgery
Applicant LUMENIS, INC. 2400 CONDENSA ST. Santa Clara,  CA  95051 -0901
ContactMartha Murari
CorrespondentMartha Murari
LUMENIS, INC. 2400 CONDENSA ST. Santa Clara,  CA  95051 -0901
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-03-14
Decision Date2005-03-31
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07290109143118 K050639 000
07290109140629 K050639 000
07290109140674 K050639 000
07290109140681 K050639 000
07290109141640 K050639 000
07290109141978 K050639 000
07290109141985 K050639 000
17290109142040 K050639 000
07290109143101 K050639 000
07290109140605 K050639 000

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