The following data is part of a premarket notification filed by Medicon Co., Ltd. with the FDA for Cleane / Cleane Pop.
| Device ID | K111341 |
| 510k Number | K111341 |
| Device Name: | CLEANE / CLEANE POP |
| Classification | Over The Counter Thermal Treatment For Acne. |
| Applicant | MEDICON CO., LTD. 951 STARBUCK ST. UNIT J Fullerton, CA 92833 |
| Contact | Priscilla Chung |
| Correspondent | Priscilla Chung MEDICON CO., LTD. 951 STARBUCK ST. UNIT J Fullerton, CA 92833 |
| Product Code | OZC |
| CFR Regulation Number | 890.5740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-12 |
| Decision Date | 2012-02-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809216198103 | K111341 | 000 |