The following data is part of a premarket notification filed by Medex, Inc. with the FDA for Medflator Ii(tm) Disposable Inflation Device.
| Device ID | K940896 |
| 510k Number | K940896 |
| Device Name: | MEDFLATOR II(TM) DISPOSABLE INFLATION DEVICE |
| Classification | Syringe, Balloon Inflation |
| Applicant | MEDEX, INC. 3637 LACON RD. Hilliard, OH 43026 |
| Contact | Cathy Chenetski |
| Correspondent | Cathy Chenetski MEDEX, INC. 3637 LACON RD. Hilliard, OH 43026 |
| Product Code | MAV |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-24 |
| Decision Date | 1994-08-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50351688510028 | K940896 | 000 |
| 50351688507974 | K940896 | 000 |
| 50351688507882 | K940896 | 000 |