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 | K130737 |
510k Number | K130737 |
Device Name: | SYNTHETIC ABSORBABLE SUTURE |
Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
Applicant | FOOSIN MEDICAL SUPPLIES INC.LTD PO BOX 120-119 Shanghai, CN 200120 |
Contact | Diana Hong |
Correspondent | Diana Hong FOOSIN MEDICAL SUPPLIES INC.LTD PO BOX 120-119 Shanghai, CN 200120 |
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 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20814639022968 | K130737 | 000 |
00840118611336 | K130737 | 000 |
00840118614740 | K130737 | 000 |
10814639026105 | K130737 | 000 |
10814639025535 | K130737 | 000 |
10814639025542 | K130737 | 000 |
10814639024873 | K130737 | 000 |
B031MVY3440 | K130737 | 000 |
B031MVY3450 | K130737 | 000 |
B031MVY3460 | K130737 | 000 |
B031MVY9220 | K130737 | 000 |
B031MVY9230 | K130737 | 000 |
B031MVY9420 | K130737 | 000 |
B031MVY9430 | K130737 | 000 |
B031MVY9670 | K130737 | 000 |
B031MVY9870 | K130737 | 000 |
00817169021131 | K130737 | 000 |
00840118611329 | K130737 | 000 |