The following data is part of a premarket notification filed by North American Instrument Corp. with the FDA for Morse Balloon Inflation Device.
| Device ID | K904275 |
| 510k Number | K904275 |
| Device Name: | MORSE BALLOON INFLATION DEVICE |
| Classification | Syringe, Balloon Inflation |
| Applicant | NORTH AMERICAN INSTRUMENT CORP. Glens Falls, NY 12801 |
| Contact | Robert Franklin |
| Correspondent | Robert Franklin NORTH AMERICAN INSTRUMENT CORP. 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 | 1990-09-18 |
| Decision Date | 1991-01-03 |