The following data is part of a premarket notification filed by Mitek Surgical Products, Inc. with the FDA for Mitek Anchor, Mitek Anchor Ii.
Device ID | K920213 |
510k Number | K920213 |
Device Name: | MITEK ANCHOR, MITEK ANCHOR II |
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 | 1992-01-16 |
Decision Date | 1992-05-01 |