The following data is part of a premarket notification filed by Depuy Mitek with the FDA for Blue Orthocord Suture.
Device ID | K043298 |
510k Number | K043298 |
Device Name: | BLUE ORTHOCORD SUTURE |
Classification | Suture, Surgical, Absorbable, Polydioxanone |
Applicant | Depuy Mitek 249 VANDERBILT DR. Norwood, MA 02062 |
Contact | Ruth C Forstadt |
Correspondent | Ruth C Forstadt Depuy Mitek 249 VANDERBILT DR. Norwood, MA 02062 |
Product Code | NEW |
CFR Regulation Number | 878.4840 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-11-30 |
Decision Date | 2004-12-10 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20886705008848 | K043298 | 000 |
20886705008831 | K043298 | 000 |
20886705008817 | K043298 | 000 |