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.
Device ID | K042233 |
510k Number | K042233 |
Device Name: | PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE |
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 | 2004-08-18 |
Decision Date | 2004-09-28 |
Summary: | summary |