BARLE TISSUE ADHESIVE 2
FDA 510(k) clearance K132243 · decided 2013-12-20
Clearance details
- K-number
- K132243
- Device name
- BARLE TISSUE ADHESIVE 2
- Applicant
- Advanced Medical Solutions (Plymouth), Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2013-07-18
- Decision date
- 2013-12-20
- Days to decision
- 155 days
- Clearance type
- Traditional
- Product code
- MPN
- Device class
- 2
- Regulation number
- 878.4010
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Plympton, Plymouth, Devon, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| a. Skin Adhesive McKesson LiquiBand Exceed 0.4 mL Liquid Dome Applicator Tip 2-Octyl Cyano recall (Z-1788-2022) | Mckesson Medical-Surgical Inc. Corporate Office | 2022-09-26 |