OTC PATCH
FDA 510(k) clearance K133723 · decided 2014-01-28
Clearance details
- K-number
- K133723
- Device name
- OTC PATCH
- Applicant
- Well-Life Healthcare Limited
- Decision
- Substantially Equivalent
- Date received
- 2013-12-06
- Decision date
- 2014-01-28
- Days to decision
- 53 days
- Clearance type
- Abbreviated
- Product code
- NUH
- Device class
- 2
- Regulation number
- 882.5890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Yunghe City, Taipei County, TW
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.