MINT

Suture, Surgical, Absorbable, Polydioxanone

HANSBIOMED CORPORATION

The following data is part of a premarket notification filed by Hansbiomed Corporation with the FDA for Mint.

Pre-market Notification Details

• Device ID: K130191
• 510k Number: K130191
• Device Name: MINT
• Classification: Suture, Surgical, Absorbable, Polydioxanone
• Applicant: HANSBIOMED CORPORATION 325 N PUENTE ST UNIT B Brea, CA 92821
• Contact: April Lee
• Correspondent: April Lee; HANSBIOMED CORPORATION 325 N PUENTE ST UNIT B Brea, CA 92821
• Product Code: NEW
• CFR Regulation Number: 878.4840 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-01-25
• Decision Date: 2013-06-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
18809556174413	K130191	000
08809204330348	K130191	000
08809204330379	K130191	000
08809204330386	K130191	000
18809779584549	K130191	000
18809556174468	K130191	000
18809556174291	K130191	000
08809556174300	K130191	000
18809556174314	K130191	000
18809556174321	K130191	000
18809556174338	K130191	000
08809204330331	K130191	000