S.E.A.L. Hemostatic Wound Spray
FDA 510(k) clearance K210751 · decided 2023-02-02
Clearance details
- K-number
- K210751
- Device name
- S.E.A.L. Hemostatic Wound Spray
- Applicant
- Bc3 Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-03-12
- Decision date
- 2023-02-02
- Days to decision
- 692 days
- Clearance type
- Traditional
- Product code
- QSY
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Baltimore, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.