The following data is part of a premarket notification filed by Zest Anchors, Inc. with the FDA for Zest Mark Ii (standard & Mini).
Device ID | K861561 |
510k Number | K861561 |
Device Name: | ZEST MARK II (STANDARD & MINI) |
Classification | Attachment, Precision, All |
Applicant | ZEST ANCHORS, INC. 8861 BALBOA AVE SUITE B San Diego, CA 92123 |
Contact | Paul Zuest |
Correspondent | Paul Zuest ZEST ANCHORS, INC. 8861 BALBOA AVE SUITE B San Diego, CA 92123 |
Product Code | EGG |
CFR Regulation Number | 872.3165 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-04-25 |
Decision Date | 1986-05-21 |