The following data is part of a premarket notification filed by Coopersurgical, Inc. with the FDA for Coopersurgical Infrared Coagulator For Ent.
| Device ID | K990855 |
| 510k Number | K990855 |
| Device Name: | COOPERSURGICAL INFRARED COAGULATOR FOR ENT |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | COOPERSURGICAL, INC. 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan COOPERSURGICAL, INC. 555 THIRTEENTH STREET, 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 | 1999-03-15 |
| Decision Date | 1999-03-30 |
| Summary: | summary |