The following data is part of a premarket notification filed by Michael Reese Hospital And Medical Center with the FDA for Amnioinfusion Catheter.
| Device ID | K862182 |
| 510k Number | K862182 |
| Device Name: | AMNIOINFUSION CATHETER |
| Classification | Monitor, Pressure, Intrauterine |
| Applicant | MICHAEL REESE HOSPITAL AND MEDICAL CENTER DEPT. OF OB-GYN LAKE SHORE DRIVE AT 31ST ST. Chicago, IL 60616 |
| Contact | Levy, M.d. |
| Correspondent | Levy, M.d. MICHAEL REESE HOSPITAL AND MEDICAL CENTER DEPT. OF OB-GYN LAKE SHORE DRIVE AT 31ST ST. Chicago, IL 60616 |
| Product Code | KXO |
| CFR Regulation Number | 884.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-09 |
| Decision Date | 1986-08-25 |