POLARUS CONNECT— 510(k) K131636
Substantially EquivalentAcumed, LLC
FDA 510(k) clearance K131636 for POLARUS CONNECT, Substantially Equivalent on 2013-10-10. Applicant: Acumed, LLC. Device class: 2.
Clearance details
- Applicant
- Acumed, LLC
- Product code
- Code LXT
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hillsboro, OR, US
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More clearances from Acumed, LLC
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