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 |