The following data is part of a premarket notification filed by Pharmacia, Inc. with the FDA for Minispace(tm) Iui Catheter.
| Device ID | K902171 |
| 510k Number | K902171 |
| Device Name: | MINISPACE(TM) IUI CATHETER |
| Classification | Cap, Cervical |
| Applicant | PHARMACIA, INC. 800 CENTENNIAL AVE. Piscataway, NJ 08854 -3911 |
| Contact | Albert P Mayo |
| Correspondent | Albert P Mayo PHARMACIA, INC. 800 CENTENNIAL AVE. Piscataway, NJ 08854 -3911 |
| Product Code | HDR |
| CFR Regulation Number | 884.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-14 |
| Decision Date | 1990-10-05 |