MEDITIME CO., LTD · 89-08 · KOREA (THE REPUBLIC OF)
For MEDITIME CO., LTD, import alert is 89-08; country is KOREA (THE REPUBLIC OF); 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 Viola Threads- PDO- TWIST 29G 38MM; product code is 79 N - - EW Suture, Surgical, Absorbable, Polydioxanone; date published is 06/17/2025; address is # 605 Medical Complex , 200 Gieopdosi Road, Jieong Myeon , Wonju, Gangwon KOREA (THE REPUBLIC OF), verified against its source on 2026-09-30.
- Firm
- MEDITIME 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
- # 605 Medical Complex , 200 Gieopdosi Road, Jieong Myeon , Wonju, Gangwon KOREA (THE REPUBLIC OF) verified
- Date published
- 06/17/2025 verified
- Product code
- 79 N - - EW Suture, Surgical, Absorbable, Polydioxanone verified
- Product
- Viola Threads- PDO- TWIST 29G 38MM verified
- FDA notes
- Class II device; requires 510(k) verified
What the source says
MEDITIME CO., LTD Date Published : 06/17/2025 # 605 Medical Complex , 200 Gieopdosi Road, Jieong Myeon , Wonju, Gangwon KOREA (THE REPUBLIC OF)
— 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 N - - EW Suture, Surgical, Absorbable, Polydioxanone Date Published: 06/17/2025 Desc: Viola Threads- PDO- TWIST 29G 38MM Notes: Class II device; requires 510(k)
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html