The following data is part of a premarket notification filed by Foosin Medical Supplies Inc.ltd with the FDA for Synthetic Absorbable Suture.
Device ID | K130735 |
510k Number | K130735 |
Device Name: | SYNTHETIC ABSORBABLE SUTURE |
Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
Applicant | FOOSIN MEDICAL SUPPLIES INC.LTD PO BOX 237-023 Shanghai, CN 200030 |
Contact | Diana Hong |
Correspondent | Diana Hong FOOSIN MEDICAL SUPPLIES INC.LTD PO BOX 237-023 Shanghai, CN 200030 |
Product Code | GAM |
CFR Regulation Number | 878.4493 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-03-18 |
Decision Date | 2014-01-14 |
Summary: | summary |