HEMCON HEMOSTATIC GEL
FDA 510(k) clearance K112215 · decided 2012-04-12
Clearance details
- K-number
- K112215
- Device name
- HEMCON HEMOSTATIC GEL
- Applicant
- Hemcon Medical Technologies Europe, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2011-08-02
- Decision date
- 2012-04-12
- Days to decision
- 254 days
- Clearance type
- Traditional
- Product code
- QSY
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Portland, OR, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.