The following data is part of a premarket notification filed by Endo Lase, Inc. with the FDA for Utilization Of Nd:yag Laser For Treatment Rectal P.
| Device ID | K851527 |
| 510k Number | K851527 |
| Device Name: | UTILIZATION OF ND:YAG LASER FOR TREATMENT RECTAL P |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ENDO LASE, INC. ATTN: JONATHAN S. KAHAN 815 CONNECTICUT AVENUE Washington, DC 20006 |
| Contact | & Hartson |
| Correspondent | & Hartson ENDO LASE, INC. ATTN: JONATHAN S. KAHAN 815 CONNECTICUT AVENUE Washington, DC 20006 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-16 |
| Decision Date | 1985-05-17 |