TIDISHEILD
FDA 510(k) clearance K132953 · decided 2014-02-18
Clearance details
- K-number
- K132953
- Device name
- TIDISHEILD
- Applicant
- Tidi Products,Llc
- Decision
- Substantially Equivalent
- Date received
- 2013-09-20
- Decision date
- 2014-02-18
- Days to decision
- 151 days
- Clearance type
- Traditional
- Product code
- PEM
- Device class
- 2
- Regulation number
- 878.4370
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Neenah, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.