The following data is part of a premarket notification filed by Curon Medical, Inc. with the FDA for Secca System.
| Device ID | K014216 |
| 510k Number | K014216 |
| Device Name: | SECCA SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | CURON MEDICAL, INC. 555 THIRTEENTH STREET, N.W. Washtington,, DC 20004 -1109 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan CURON MEDICAL, INC. 555 THIRTEENTH STREET, N.W. Washtington,, 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 | 2001-12-21 |
| Decision Date | 2002-03-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856219002003 | K014216 | 000 |