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 |