Polar Care Wave— 510(k) K183702
Substantially EquivalentBreg, Inc.
FDA 510(k) clearance K183702 for Polar Care Wave, Substantially Equivalent on 2019-03-01. Applicant: Breg, Inc.. Device class: 2.
Clearance details
- Applicant
- Breg, Inc.
- Product code
- Code IRP
- Device class
- Class 2
- Regulation
- 21 CFR 890.5650
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carlsbad, CA, US
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