The following data is part of a premarket notification filed by Endo Lase, Inc. with the FDA for Endo-lse Cd-100 Co2 Laser For Gynecology.
| Device ID | K853876 |
| 510k Number | K853876 |
| Device Name: | ENDO-LSE CD-100 CO2 LASER FOR GYNECOLOGY |
| Classification | Laser, Surgical, Gynecologic |
| Applicant | ENDO LASE, INC. ATTN: JONATHAN S. KAHAN 815 CONNECTICUT AVENUE Washington, DC 20006 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan ENDO LASE, INC. ATTN: JONATHAN S. KAHAN 815 CONNECTICUT AVENUE Washington, DC 20006 |
| Product Code | HHR |
| CFR Regulation Number | 884.4550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-17 |
| Decision Date | 1986-02-21 |