The following data is part of a premarket notification filed by Ovamed Corp. with the FDA for Ovamed Intrauterine Access Catheter.
| Device ID | K931534 |
| 510k Number | K931534 |
| Device Name: | OVAMED INTRAUTERINE ACCESS CATHETER |
| Classification | Catheters, Salpingography |
| Applicant | OVAMED CORP. 111 WEST EVELYN AVENUE, SUITE 214 Sunnyvale, CA 94086 |
| Contact | Christine Decaria |
| Correspondent | Christine Decaria OVAMED CORP. 111 WEST EVELYN AVENUE, SUITE 214 Sunnyvale, CA 94086 |
| Product Code | MOV |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-29 |
| Decision Date | 1995-07-28 |