The following data is part of a premarket notification filed by Zest Anchors, Inc. with the FDA for Locator Implant Anchor.
Device ID | K994257 |
510k Number | K994257 |
Device Name: | LOCATOR IMPLANT ANCHOR |
Classification | Implant, Endosseous, Root-form |
Applicant | ZEST ANCHORS, INC. 2061 WINERIDGE PL., SUITE 100 Escondido, CA 92029 |
Contact | Paul Zuest |
Correspondent | Paul Zuest ZEST ANCHORS, INC. 2061 WINERIDGE PL., SUITE 100 Escondido, CA 92029 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-12-16 |
Decision Date | 2000-03-17 |
Summary: | summary |