The following data is part of a premarket notification filed by Zest Anchors, Inc. with the FDA for Zest Plant.
Device ID | K801524 |
510k Number | K801524 |
Device Name: | ZEST PLANT |
Classification | Implant, Endosseous, Root-form |
Applicant | ZEST ANCHORS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-07-01 |
Decision Date | 1980-07-21 |