The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for Lupine Loop.
Device ID | K050771 |
510k Number | K050771 |
Device Name: | LUPINE LOOP |
Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
Applicant | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 249 VANDERBILT AVE. Norwood, MA 02062 |
Contact | Denise Luciano |
Correspondent | Denise Luciano DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 249 VANDERBILT AVE. Norwood, MA 02062 |
Product Code | GAM |
CFR Regulation Number | 878.4493 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-03-25 |
Decision Date | 2005-04-08 |
Summary: | summary |