510(k) K882063
K882063 is an FDA 510(k) premarket notification submitted by Zest Anchors, Inc. for the device "MAGNE-DENT MAGNET/ZEST RETROFIT KEEPER". The FDA issued a decision of Substantially Equivalent on June 13, 1988. The device falls under product code EGG (Attachment, Precision, All), a Class I device regulated under 21 CFR 872.3165. Zest Anchors, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 13, 1988
- Date Received
- May 16, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Attachment, Precision, All
- Device Class
- Class I
- Regulation Number
- 872.3165
- Review Panel
- DE
- Submission Type