The following data is part of a premarket notification filed by Mitek Products with the FDA for Mitek Fastin Rc Anchor.
Device ID | K983818 |
510k Number | K983818 |
Device Name: | MITEK FASTIN RC ANCHOR |
Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
Applicant | MITEK PRODUCTS 60 GLACIER DR. Westwood, MA 02090 |
Contact | Edward F Kent |
Correspondent | Edward F Kent MITEK PRODUCTS 60 GLACIER DR. Westwood, MA 02090 |
Product Code | MBI |
Subsequent Product Code | GAM |
Subsequent Product Code | GAS |
Subsequent Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-10-29 |
Decision Date | 1998-11-23 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10886705008285 | K983818 | 000 |