The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for Passing Needle With Ethibond, Panacryl Or Orthocord Suture; And Passing Needle With Ethibond Loop.
| Device ID | K041806 |
| 510k Number | K041806 |
| Device Name: | PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE; AND PASSING NEEDLE WITH ETHIBOND LOOP |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 249 VANDERBILT AVE. Norwood, MA 02062 |
| Contact | Ruth C Forstadt |
| Correspondent | Ruth C Forstadt DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 249 VANDERBILT AVE. Norwood, MA 02062 |
| Product Code | GAM |
| Subsequent Product Code | GAT |
| Subsequent Product Code | NEW |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-06 |
| Decision Date | 2004-08-03 |
| Summary: | summary |