CORELEADER ALGIPLASTER MODEL AP 050501
FDA 510(k) clearance K102942 · decided 2011-06-22
Clearance details
- K-number
- K102942
- Device name
- CORELEADER ALGIPLASTER MODEL AP 050501
- Applicant
- Coreleader Biotech Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2010-10-04
- Decision date
- 2011-06-22
- Days to decision
- 261 days
- Clearance type
- Traditional
- Product code
- FRO
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Taipei, Taiwan, TW
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.