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 |