The following data is part of a premarket notification filed by Namic with the FDA for Breeze Digital Inflation Device.
| Device ID | K953676 |
| 510k Number | K953676 |
| Device Name: | BREEZE DIGITAL INFLATION DEVICE |
| Classification | Syringe, Balloon Inflation |
| Applicant | NAMIC PRUYNS ISLAND Glens Falls, NY 12801 |
| Contact | Mary Meagher Rubin |
| Correspondent | Mary Meagher Rubin NAMIC PRUYNS ISLAND Glens Falls, NY 12801 |
| Product Code | MAV |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-07 |
| Decision Date | 1996-03-29 |
| Summary: | summary |