The following data is part of a premarket notification filed by Medex, Inc. with the FDA for Medflator Inflation System.
| Device ID | K910958 |
| 510k Number | K910958 |
| Device Name: | MEDFLATOR INFLATION SYSTEM |
| Classification | Syringe, Balloon Inflation |
| Applicant | MEDEX, INC. 6250 SHIER RINGS RD. Dublin, OH 40316 |
| Contact | Cathy Chenetski |
| Correspondent | Cathy Chenetski MEDEX, INC. 6250 SHIER RINGS RD. Dublin, OH 40316 |
| Product Code | MAV |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-06 |
| Decision Date | 1991-07-12 |