The following data is part of a premarket notification filed by Boston Endo Surgical Tech, with the FDA for Nav Pak Needle, Nim Nav Pak Needle.
| Device ID | K182662 |
| 510k Number | K182662 |
| Device Name: | NAV PAK Needle, NIM NAV PAK Needle |
| Classification | Neurosurgical Nerve Locator |
| Applicant | Boston Endo Surgical Tech, Division Of Lacey Manufacturing Co., LLC 1146 Barnum Ave Bridgeport, CT 06610 |
| Contact | James Rogers |
| Correspondent | James Rogers Boston Endo Surgical Tech, Division Of Lacey Manufacturing Co., LLC 1146 Barnum Ave Bridgeport, CT 06610 |
| Product Code | PDQ |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-25 |
| Decision Date | 2019-04-10 |