SUNTOUCH TOPICAL HEMOSTATIC DRESSING
FDA 510(k) clearance K112800 · decided 2012-05-23
Clearance details
- K-number
- K112800
- Device name
- SUNTOUCH TOPICAL HEMOSTATIC DRESSING
- Applicant
- Huizhou Foryou Medical Devices Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2011-09-27
- Decision date
- 2012-05-23
- Days to decision
- 239 days
- Clearance type
- Traditional
- Product code
- QSY
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Pennington, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ActCel advanced bleeding control Topical Hemostatic Dressing 2in X 2in (5cm X 5cm) 4in X 4 recall (Z-1697-2015) | Coreva Health Science LLC | 2015-05-30 |