The following data is part of a premarket notification filed by Sutures India Pvt., Ltd. with the FDA for Monoglyde, Absorbable (poliglecaprone 25) Suture.
| Device ID | K081002 |
| 510k Number | K081002 |
| Device Name: | MONOGLYDE, ABSORBABLE (POLIGLECAPRONE 25) 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 |
| Summary: | summary |