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 |