The following data is part of a premarket notification filed by Mitek Surgical Products, Inc. with the FDA for Quickanchor.
Device ID | K924665 |
510k Number | K924665 |
Device Name: | QUICKANCHOR |
Classification | Staple, Fixation, Bone |
Applicant | MITEK SURGICAL PRODUCTS, INC. 57 PROVIDENCE HWY. Norwood, MA 02062 |
Contact | Robert P Zoletti |
Correspondent | Robert P Zoletti MITEK SURGICAL PRODUCTS, INC. 57 PROVIDENCE HWY. Norwood, MA 02062 |
Product Code | JDR |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-09-10 |
Decision Date | 1992-10-27 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
QUICKANCHOR 75579882 2384755 Live/Registered |
JOHNSON & JOHNSON 1998-10-30 |
QUICKANCHOR 74167366 1686231 Dead/Cancelled |
Mitek Surgical Products, Inc. 1991-05-14 |