The following data is part of a premarket notification filed by Lumenis, Inc. with the FDA for Lumenis Versacut Tissue Morcellator System.
Device ID | K050639 |
510k Number | K050639 |
Device Name: | LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEM |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | LUMENIS, INC. 2400 CONDENSA ST. Santa Clara, CA 95051 -0901 |
Contact | Martha Murari |
Correspondent | Martha Murari LUMENIS, INC. 2400 CONDENSA ST. Santa Clara, CA 95051 -0901 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-03-14 |
Decision Date | 2005-03-31 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
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 |