The following data is part of a premarket notification filed by Mitek Surgical Products, Inc. with the FDA for Mitek Gii Anchor.
Device ID | K953877 |
510k Number | K953877 |
Device Name: | MITEK GII ANCHOR |
Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
Applicant | MITEK SURGICAL PRODUCTS, INC. 60 GLACIER DR. Westwood, MA 02090 |
Contact | Edward F Kent |
Correspondent | Edward F Kent MITEK SURGICAL PRODUCTS, INC. 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 | 1995-07-17 |
Decision Date | 1995-12-29 |