Viola

Suture, Surgical, Absorbable, Polydioxanone

MEDITIME Co., Ltd

The following data is part of a premarket notification filed by Meditime Co., Ltd with the FDA for Viola.

Pre-market Notification Details

• Device ID: K190264
• 510k Number: K190264
• Device Name: Viola
• Classification: Suture, Surgical, Absorbable, Polydioxanone
• Applicant: MEDITIME Co., Ltd #605 Medical Device Complex, 200, Gieupdosi-ro, Jijeong-Myeon Won Ju, KR 90010
• Contact: Yong Baik Kim
• Correspondent: Young Chi; Bio-Med USA Inc 27 New England Drive Ramsey, NJ 07446
• Product Code: NEW
• CFR Regulation Number: 878.4840 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-02-08
• Decision Date: 2019-08-15