The following data is part of a premarket notification filed by Depuy Mitek with the FDA for Orthocord Suture.
Device ID | K040004 |
510k Number | K040004 |
Device Name: | 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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-01-02 |
Decision Date | 2004-04-13 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20886705008862 | K040004 | 000 |
20886705008855 | K040004 | 000 |
20886705008763 | K040004 | 000 |
20886705008756 | K040004 | 000 |
20886705008749 | K040004 | 000 |
20886705008732 | K040004 | 000 |