The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for Gii Quickanchor Plus.
Device ID | K041115 |
510k Number | K041115 |
Device Name: | GII QUICKANCHOR PLUS |
Classification | Staple, Fixation, Bone |
Applicant | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 249 VANDERBILT AVE. Norwood, MA 02062 |
Contact | Allyson Barford |
Correspondent | Allyson Barford DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 249 VANDERBILT AVE. Norwood, MA 02062 |
Product Code | JDR |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-04-29 |
Decision Date | 2004-05-28 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
GII QUICKANCHOR PLUS 76577706 2932531 Live/Registered |
JOHNSON & JOHNSON 2004-02-26 |