The following data is part of a premarket notification filed by Sutures India Private Limited with the FDA for Trulene Non-absorbable Polypropylene Surgical Suture.
| Device ID | K041511 |
| 510k Number | K041511 |
| Device Name: | TRULENE NON-ABSORBABLE POLYPROPYLENE SURGICAL SUTURE |
| Classification | Suture, Nonabsorbable, Synthetic, Polypropylene |
| Applicant | SUTURES INDIA PRIVATE LIMITED 118, 3RD PHASE PEENYA INDUSTRIAL AREA Bangalore, IN 560-058 |
| Contact | L.g. Chandrasekhar |
| Correspondent | L.g. Chandrasekhar SUTURES INDIA PRIVATE LIMITED 118, 3RD PHASE PEENYA INDUSTRIAL AREA Bangalore, IN 560-058 |
| Product Code | GAW |
| CFR Regulation Number | 878.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-07 |
| Decision Date | 2005-06-03 |
| Summary: | summary |