The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for Rc Loop /dual Orthocord Suture,rc Loop W/ethibond Suture,rc Loop W/panacryl Suture.
| Device ID | K060553 |
| 510k Number | K060553 |
| Device Name: | RC LOOP /DUAL ORTHOCORD SUTURE,RC LOOP W/ETHIBOND SUTURE,RC LOOP W/PANACRYL SUTURE |
| Classification | Staple, Fixation, Bone |
| Applicant | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Kristine Christo |
| Correspondent | Kristine Christo DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-01 |
| Decision Date | 2006-05-04 |
| Summary: | summary |