The following data is part of a premarket notification filed by North American Instrument Corp. with the FDA for Namic Contrast & Fluid Delivery Spikes(various).
| Device ID | K852140 |
| 510k Number | K852140 |
| Device Name: | NAMIC CONTRAST & FLUID DELIVERY SPIKES(VARIOUS) |
| Classification | Set, Administration, Intravascular |
| Applicant | NORTH AMERICAN INSTRUMENT CORP. Hudson Falls, NY 12839 |
| Contact | Phillip H Morse |
| Correspondent | Phillip H Morse NORTH AMERICAN INSTRUMENT CORP. Hudson Falls, NY 12839 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-16 |
| Decision Date | 1985-05-30 |