CLEANE / CLEANE POP
FDA 510(k) clearance K111341 · decided 2012-02-29
Clearance details
- K-number
- K111341
- Device name
- CLEANE / CLEANE POP
- Applicant
- Medicon Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2011-05-12
- Decision date
- 2012-02-29
- Days to decision
- 293 days
- Clearance type
- Traditional
- Product code
- OZC
- Device class
- 2
- Regulation number
- 890.5740
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Fullerton, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.