Hemostatic Xerogel Sponge
FDA 510(k) clearance K192671 · decided 2020-08-28
Clearance details
- K-number
- K192671
- Device name
- Hemostatic Xerogel Sponge
- Applicant
- Solaplus Biotech Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2019-09-26
- Decision date
- 2020-08-28
- Days to decision
- 337 days
- Clearance type
- Traditional
- Product code
- QSY
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Wenzhou, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.