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 |