The following data is part of a premarket notification filed by Hogan & Hartson with the FDA for Redfield Infrared Coagulator.
| Device ID | K950836 |
| 510k Number | K950836 |
| Device Name: | REDFIELD INFRARED COAGULATOR |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | HOGAN & HARTSON COLUMBIA SQUARE 555 THIRTEENTH STREET N.W. Washington, DC 20004 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan HOGAN & HARTSON COLUMBIA SQUARE 555 THIRTEENTH STREET N.W. Washington, DC 20004 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-24 |
| Decision Date | 1995-03-24 |