The following data is part of a premarket notification filed by Teleflex Medical with the FDA for Polyglytone 6211 Synthetic Absorbable Suture.
| Device ID | K042141 |
| 510k Number | K042141 |
| Device Name: | POLYGLYTONE 6211 SYNTHETIC ABSORBABLE SUTURE |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | TELEFLEX MEDICAL 600 AIRPORT RD. Fall River, MA 02720 -4740 |
| Contact | Steve Astorino |
| Correspondent | Steve Astorino TELEFLEX MEDICAL 600 AIRPORT RD. Fall River, MA 02720 -4740 |
| Product Code | GAM |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-09 |
| Decision Date | 2004-09-28 |
| Summary: | summary |