PIP Fix— 510(k) K181192
Substantially EquivalentHand Biomechanics Lab, Inc.
FDA 510(k) clearance K181192 for PIP Fix, Substantially Equivalent on 2018-10-22. Applicant: Hand Biomechanics Lab, Inc.. Device class: 2.
Clearance details
- Applicant
- Hand Biomechanics Lab, Inc.
- Product code
- Code JEC
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sacramento, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.