The following data is part of a premarket notification filed by Conway Stuart Medical, Inc. with the FDA for Csm Stretta System.
| Device ID | K000245 |
| 510k Number | K000245 |
| Device Name: | CSM STRETTA SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | CONWAY STUART MEDICAL, INC. 555 THIRTEENTH ST. N.W. Washington, DC 20004 -1109 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan CONWAY STUART MEDICAL, INC. 555 THIRTEENTH ST. N.W. Washington, DC 20004 -1109 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-27 |
| Decision Date | 2000-04-18 |