Empty EVA Bag
FDA 510(k) clearance K193528 · decided 2020-07-22
Clearance details
- K-number
- K193528
- Device name
- Empty EVA Bag
- Applicant
- Haemotronic S.P.A.
- Decision
- Substantially Equivalent
- Date received
- 2019-12-19
- Decision date
- 2020-07-22
- Days to decision
- 216 days
- Clearance type
- Traditional
- Product code
- KPE
- Device class
- 2
- Regulation number
- 880.5025
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mirandola, IT
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.