The following data is part of a premarket notification filed by Mitek Surgical Products, Inc. with the FDA for Quickanchor, Modification.
Device ID | K921873 |
510k Number | K921873 |
Device Name: | QUICKANCHOR, MODIFICATION |
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 | 1992-04-08 |
Decision Date | 1992-06-09 |