The following data is part of a premarket notification filed by North American Instrument Corp. with the FDA for Namic Homer Mammalok Needle/wire Localizer.
Device ID | K852402 |
510k Number | K852402 |
Device Name: | NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZER |
Classification | Guide, Surgical, Instrument |
Applicant | NORTH AMERICAN INSTRUMENT CORP. Hudson Falls, NY 12839 |
Contact | Philip H Morse |
Correspondent | Philip H Morse NORTH AMERICAN INSTRUMENT CORP. Hudson Falls, NY 12839 |
Product Code | FZX |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-06-06 |
Decision Date | 1985-07-11 |