The following data is part of a premarket notification filed by Epcom Medical Systems, Inc. with the FDA for Intrauterine Catheter Set.
| Device ID | K905812 |
| 510k Number | K905812 |
| Device Name: | INTRAUTERINE CATHETER SET |
| Classification | Catheter, Intrauterine And Introducer |
| Applicant | EPCOM MEDICAL SYSTEMS, INC. 302 LINDBERGH AVE. Livermore, CA 94550 |
| Contact | Cheryl Kutchera |
| Correspondent | Cheryl Kutchera EPCOM MEDICAL SYSTEMS, INC. 302 LINDBERGH AVE. Livermore, CA 94550 |
| Product Code | HGS |
| CFR Regulation Number | 884.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-28 |
| Decision Date | 1991-01-31 |