HS AMICA DEVICES FAMILY
FDA 510(k) clearance K150112 · decided 2015-09-10
Clearance details
- K-number
- K150112
- Device name
- HS AMICA DEVICES FAMILY
- Applicant
- H.S Hospital Service S.P.A
- Decision
- Substantially Equivalent
- Date received
- 2015-01-20
- Decision date
- 2015-09-10
- Days to decision
- 233 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Aprilia (Lt), IT
- 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.