Young Chemical Co., Ltd. · 89-08 · KOREA (THE REPUBLIC OF)
For Young Chemical Co., Ltd. · 89-08 · KOREA (THE REPUBLIC OF), import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is KOREA (THE REPUBLIC OF); product is Acne Pimple Master Patch | Acne Pimple Master Patch; product code is 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 79 N - - AC Dressing, Wound, Hydrophilic; date published is 06/08/2017; address is 80-93 Golden Root-Ro , Juchon-Myeon , Gimhae-Si, Gyeongnam KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.
- Firm
- Young Chemical Co., Ltd. verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- KOREA (THE REPUBLIC OF) verified
- Address
- 80-93 Golden Root-Ro , Juchon-Myeon , Gimhae-Si, Gyeongnam KOREA (THE REPUBLIC OF) verified
- Date published
- 06/08/2017 verified
- Product code
- 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 79 N - - AC Dressing, Wound, Hydrophilic each item verified
- Product
- Acne Pimple Master Patch | Acne Pimple Master Patch each item verified
- FDA notes
- Class I device without a valid 510k | Class I device without a valid 510k each item verified
What the source says
Young Chemical Co., Ltd. Date Published : 06/08/2017 80-93 Golden Root-Ro , Juchon-Myeon , Gimhae-Si, Gyeongnam KOREA (THE REPUBLIC OF) 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 06/08/2017 Desc: Acne Pimple Master Patch Notes: Class I device without a valid 510k 79 N - - AC Dressing, Wound, Hydrophilic Date Published: 06/08/2017 Desc: Acne Pimple Master Patch Notes: Class I device without a valid 510k
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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