ORTHODEK
Suture, Absorbable, Synthetic, Polyglycolic Acid
TELEFLEX MEDICAL
The following data is part of a premarket notification filed by Teleflex Medical with the FDA for Orthodek.
Pre-market Notification Details
| Device ID | K033115 |
| 510k Number | K033115 |
| Device Name: | ORTHODEK |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | TELEFLEX MEDICAL 600 AIRPORT RD. Fall River, MA 02720 -4740 |
| Contact | Stephen Page |
| Correspondent | Stephen Page 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 | 2003-09-30 |
| Decision Date | 2003-11-17 |
| Summary: | summary |
Trademark Results [ORTHODEK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ORTHODEK 88732310 not registered Live/Pending |
Vepo, Ltd. 2019-12-18 |
 ORTHODEK 78715931 3432836 Dead/Cancelled |
TELEFLEX MEDICAL INCORPORATED 2005-09-19 |
 ORTHODEK 78095482 not registered Dead/Abandoned |
TELEFLEX-CT DEVICES INCORPORATED 2001-11-28 |
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