The following data is part of a premarket notification filed by Sutures India Pvt., Ltd. with the FDA for Trusynth, Absorbable (polyglactin 910) Suture.
Device ID | K081003 |
510k Number | K081003 |
Device Name: | TRUSYNTH, ABSORBABLE (POLYGLACTIN 910) SUTURE |
Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
Applicant | SUTURES INDIA PVT., LTD. 472 D, 13TH CROSS, 4TH PHASE PEENYA INDUSTRIAL AREA Bangalore, IN 560058 |
Contact | L.g. Chandrasekhar |
Correspondent | L.g. Chandrasekhar SUTURES INDIA PVT., LTD. 472 D, 13TH CROSS, 4TH PHASE PEENYA INDUSTRIAL AREA Bangalore, IN 560058 |
Product Code | GAM |
CFR Regulation Number | 878.4493 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-04-08 |
Decision Date | 2008-06-09 |