ReGrasp— 510(k) K153163
Substantially EquivalentRehabtronics, Inc.
FDA 510(k) clearance K153163 for ReGrasp, Substantially Equivalent on 2016-04-07. Applicant: Rehabtronics, Inc.. Device class: 2.
Clearance details
- Applicant
- Rehabtronics, Inc.
- Product code
- Code GZI
- Device class
- Class 2
- Regulation
- 21 CFR 882.5810
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Edmonton, CA
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