Axiostat Patch
FDA 510(k) clearance K202830 · decided 2021-04-15
Clearance details
- K-number
- K202830
- Device name
- Axiostat Patch
- Applicant
- Advamedica, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-09-25
- Decision date
- 2021-04-15
- Days to decision
- 202 days
- Clearance type
- Traditional
- Product code
- QSY
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Cambridge, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.