The following data is part of a premarket notification filed by Teleflex Medical Group with the FDA for Kmedic External Fixation Devices.
Device ID | K030336 |
510k Number | K030336 |
Device Name: | KMEDIC EXTERNAL FIXATION DEVICES |
Classification | Pin, Fixation, Threaded |
Applicant | TELEFLEX MEDICAL GROUP 50 PLANTATION DR. Jaffrey, NH 03452 |
Contact | Rick Lykins |
Correspondent | Rick Lykins TELEFLEX MEDICAL GROUP 50 PLANTATION DR. Jaffrey, NH 03452 |
Product Code | JDW |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-01-31 |
Decision Date | 2003-03-06 |
Summary: | summary |