The following data is part of a premarket notification filed by Endo Lase, Inc. with the FDA for Infrared Coagulator.
| Device ID | K842810 |
| 510k Number | K842810 |
| Device Name: | INFRARED COAGULATOR |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | ENDO LASE, INC. 815 CONNECTICUT AVE., N.W. Washington, DC 20006 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan ENDO LASE, INC. 815 CONNECTICUT AVE., N.W. Washington, DC 20006 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-18 |
| Decision Date | 1984-10-18 |