The following data is part of a premarket notification filed by Mitek Products with the FDA for Talon Anchor Snap-pak.
Device ID | K993261 |
510k Number | K993261 |
Device Name: | TALON ANCHOR SNAP-PAK |
Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
Applicant | MITEK PRODUCTS 60 GLACIER DR. Westwood, MA 02090 |
Contact | Paula A Bulger |
Correspondent | Paula A Bulger MITEK PRODUCTS 60 GLACIER DR. Westwood, MA 02090 |
Product Code | MBI |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-09-29 |
Decision Date | 1999-12-02 |
Summary: | summary |