The following data is part of a premarket notification filed by Lumenis, Inc. with the FDA for Coherent Tissue Morcellator Kit And Accessories.
| Device ID | K980079 |
| 510k Number | K980079 |
| Device Name: | COHERENT TISSUE MORCELLATOR KIT AND ACCESSORIES |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | LUMENIS, INC. 3270 WEST BAYSHORE RD. POST OFFICE BOX 10122 Palo Alto, CA 94303 -0810 |
| Contact | Anne Worden |
| Correspondent | Anne Worden LUMENIS, INC. 3270 WEST BAYSHORE RD. POST OFFICE BOX 10122 Palo Alto, CA 94303 -0810 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-09 |
| Decision Date | 1998-04-09 |
| Summary: | summary |