The following data is part of a premarket notification filed by Epcom Medical Systems, Inc. with the FDA for Cervicath.
| Device ID | K881414 |
| 510k Number | K881414 |
| Device Name: | CERVICATH |
| Classification | Cap, Cervical |
| Applicant | EPCOM MEDICAL SYSTEMS, INC. 302 LINDBERGH AVE. Livermore, CA 94550 |
| Contact | Paul Ulbrich |
| Correspondent | Paul Ulbrich EPCOM MEDICAL SYSTEMS, INC. 302 LINDBERGH AVE. Livermore, CA 94550 |
| Product Code | HDR |
| CFR Regulation Number | 884.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-04 |
| Decision Date | 1988-06-14 |