TRONLINK TECHNOLOGY CO.,LTD · 89-08 · TAIWAN
For TRONLINK TECHNOLOGY CO.,LTD, import alert is 89-08; country is TAIWAN; 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)"; product is Skin tag Removal kit; product code is 79 G - - DJ Clamp, Surgical, General & Plastic Surgery; date published is 10/04/2017; address is No.444 , 2, 3 F.; Jianguo N. Rd. Sec. 1; Zhongshan Dist. , Taipei City, TAIWAN, verified against its source on 2026-09-30.
- Firm
- TRONLINK TECHNOLOGY 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
- TAIWAN verified
- Address
- No.444 , 2, 3 F.; Jianguo N. Rd. Sec. 1; Zhongshan Dist. , Taipei City, TAIWAN verified
- Date published
- 10/04/2017 verified
- Product code
- 79 G - - DJ Clamp, Surgical, General & Plastic Surgery verified
- Product
- Skin tag Removal kit verified
- FDA notes
- Class I device without a valid 510K verified
What the source says
TRONLINK TECHNOLOGY CO.,LTD Date Published : 10/04/2017 No.444 , 2, 3 F.; Jianguo N. Rd. Sec. 1; Zhongshan Dist. , Taipei City, TAIWAN
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
79 G - - DJ Clamp, Surgical, General & Plastic Surgery Date Published: 10/04/2017 Desc: Skin tag Removal kit Notes: Class I device without a valid 510K
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html