The following data is part of a premarket notification filed by Select Medical Systems, Inc. with the FDA for Thecurve, Item 507.
| Device ID | K012935 |
| 510k Number | K012935 |
| Device Name: | THECURVE, ITEM 507 |
| Classification | Cannula, Intrauterine Insemination |
| Applicant | SELECT MEDICAL SYSTEMS, INC. P.O. BOX 966 Williston, VT 05495 -0966 |
| Contact | Monique Girard |
| Correspondent | Monique Girard SELECT MEDICAL SYSTEMS, INC. P.O. BOX 966 Williston, VT 05495 -0966 |
| Product Code | MFD |
| CFR Regulation Number | 884.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-31 |
| Decision Date | 2001-10-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60888937003644 | K012935 | 000 |
| 20888937003608 | K012935 | 000 |