The following data is part of a premarket notification filed by Zest Anchors, Inc. with the FDA for Magne-dent Magnet/zest Retrofit Keeper.
Device ID | K882063 |
510k Number | K882063 |
Device Name: | MAGNE-DENT MAGNET/ZEST RETROFIT KEEPER |
Classification | Attachment, Precision, All |
Applicant | ZEST ANCHORS, INC. 8861 BALBOA AVE SUITE B San Diego, CA 92123 |
Contact | Paul Zest |
Correspondent | Paul Zest 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 | 1988-05-16 |
Decision Date | 1988-06-13 |