NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe— 510(k) K180542
Substantially EquivalentBoston Endo Surgical Tech,
FDA 510(k) clearance K180542 for NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe, Substantially Equivalent on 2018-08-22. Applicant: Boston Endo Surgical Tech,. Device class: 2.
Clearance details
- Applicant
- Boston Endo Surgical Tech,
- Product code
- Code PDQ
- Device class
- Class 2
- Regulation
- 21 CFR 874.1820
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bridgeport, CT, US
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