The following data is part of a premarket notification filed by Hogan & Hartson with the FDA for Coopersurgical Infrared Coagulator.
| Device ID | K974168 |
| 510k Number | K974168 |
| Device Name: | COOPERSURGICAL INFRARED COAGULATOR |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | HOGAN & HARTSON 555 13TH ST., N.W. Washington, DC 20004 -1109 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan HOGAN & HARTSON 555 13TH ST., N.W. Washington, DC 20004 -1109 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-05 |
| Decision Date | 1998-01-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888937013504 | K974168 | 000 |
| 00888937013283 | K974168 | 000 |
| 00888937013276 | K974168 | 000 |
| 00888937013269 | K974168 | 000 |
| 20888937013256 | K974168 | 000 |
| 20888937013249 | K974168 | 000 |