The following data is part of a premarket notification filed by Gynopharma, Inc. with the FDA for Slimcath (tm).
| Device ID | K903001 |
| 510k Number | K903001 |
| Device Name: | SLIMCATH (TM) |
| Classification | Tester, Color Vision |
| Applicant | GYNOPHARMA, INC. C/O ELLIS PHARM CONSULTING INC 913 STATE ROAD Princeton, NJ 08540 |
| Contact | Levi Ellis |
| Correspondent | Levi Ellis GYNOPHARMA, INC. C/O ELLIS PHARM CONSULTING INC 913 STATE ROAD Princeton, NJ 08540 |
| Product Code | HIT |
| CFR Regulation Number | 886.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-09 |
| Decision Date | 1991-06-25 |