The following data is part of a premarket notification filed by Ram Development with the FDA for Intrauterine Catheter.
| Device ID | K861305 |
| 510k Number | K861305 |
| Device Name: | INTRAUTERINE CATHETER |
| Classification | Cap, Cervical |
| Applicant | RAM DEVELOPMENT 28 REMEZ ST NES-ZIONA 70400 Israel, IL |
| Contact | Itzik Rabinovitz |
| Correspondent | Itzik Rabinovitz RAM DEVELOPMENT 28 REMEZ ST NES-ZIONA 70400 Israel, IL |
| Product Code | HDR |
| CFR Regulation Number | 884.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-07 |
| Decision Date | 1986-12-11 |