The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Trigen Intertan.
Device ID | K040212 |
510k Number | K040212 |
Device Name: | TRIGEN INTERTAN |
Classification | Nail, Fixation, Bone |
Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
Contact | Kim Kelly |
Correspondent | Kim Kelly SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
Product Code | JDS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-01-30 |
Decision Date | 2004-02-20 |
Summary: | summary |