The following data is part of a premarket notification filed by Imagyn Medical, Inc. with the FDA for Imagyn Medical Inflation Device With Non-invasive Pressure Tubing.
| Device ID | K940425 |
| 510k Number | K940425 |
| Device Name: | IMAGYN MEDICAL INFLATION DEVICE WITH NON-INVASIVE PRESSURE TUBING |
| Classification | Syringe, Balloon Inflation |
| Applicant | IMAGYN MEDICAL, INC. 27651 LA PAZ RD. Laguna Niguel, CA 92656 -3917 |
| Contact | Guy R Lowery |
| Correspondent | Guy R Lowery IMAGYN MEDICAL, INC. 27651 LA PAZ RD. Laguna Niguel, CA 92656 -3917 |
| Product Code | MAV |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-31 |
| Decision Date | 1994-08-01 |