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 |