The following data is part of a premarket notification filed by Endo Lase, Inc. with the FDA for Nd. Yag Laser Rectal Pathology.
| Device ID | K844460 |
| 510k Number | K844460 |
| Device Name: | ND. YAG LASER RECTAL PATHOLOGY |
| Classification | Laser For Gastro-urology Use |
| 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 | LNK |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-15 |
| Decision Date | 1985-01-16 |