The following data is part of a premarket notification filed by Medical Measurements, Inc. with the FDA for Mmi/gaeltec Catheter Intrauterine.
| Device ID | K801758 |
| 510k Number | K801758 |
| Device Name: | MMI/GAELTEC CATHETER INTRAUTERINE |
| Classification | Monitor, Pressure, Intrauterine |
| Applicant | MEDICAL MEASUREMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KXO |
| CFR Regulation Number | 884.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-07-28 |
| Decision Date | 1980-08-14 |