The following data is part of a premarket notification filed by Mitek Products with the FDA for Mitek Micro Anchor.
Device ID | K962793 |
510k Number | K962793 |
Device Name: | MITEK MICRO ANCHOR |
Classification | Staple, Fixation, Bone |
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 | JDR |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-07-17 |
Decision Date | 1996-10-01 |
Summary: | summary |