The following data is part of a premarket notification filed by North American Instrument Corp. with the FDA for Namic Contrast Savings Delivery System.
| Device ID | K903493 |
| 510k Number | K903493 |
| Device Name: | NAMIC CONTRAST SAVINGS DELIVERY SYSTEM |
| Classification | System, X-ray, Angiographic |
| Applicant | NORTH AMERICAN INSTRUMENT CORP. Glens Falls, NY 12801 |
| Contact | Robert E Franklin |
| Correspondent | Robert E Franklin NORTH AMERICAN INSTRUMENT CORP. Glens Falls, NY 12801 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-03 |
| Decision Date | 1991-03-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H965640009551 | K903493 | 000 |
| 20193489068198 | K903493 | 000 |
| 20193489068204 | K903493 | 000 |
| 20193489068099 | K903493 | 000 |
| 20193489140177 | K903493 | 000 |
| 20193489058823 | K903493 | 000 |
| 20193489058830 | K903493 | 000 |
| 20193489058991 | K903493 | 000 |
| 20193489059028 | K903493 | 000 |
| 10193489066920 | K903493 | 000 |
| H749904004351 | K903493 | 000 |
| H965640000901 | K903493 | 000 |
| 20193489068181 | K903493 | 000 |