510(k) K111341
- Device
- CLEANE / CLEANE POP
- Applicant
- MEDICON CO., LTD.
- 510(k) number
- K111341
- Product code
- OZC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-02-29
- Date received
- 2011-05-12
- Regulation
- 890.5740
- Classification name
- Over The Counter Thermal Treatment For Acne.
- Medical specialty
- Physical Medicine
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Priscilla Chung
- Address
- 951 St.Arbuck St. Unit J Fullerton CA US 92833 92833
FDA Registration Numbers#
- 3009862779
Source Documents#
Legacy Summary#
summary
FDA Review#
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