510(k) K925700
K925700 is an FDA 510(k) premarket notification submitted by Zest Anchors, Inc. for the device "ZEST ANCHOR ADVANCED GENERATION". The FDA issued a decision of Substantially Equivalent on April 7, 1994. 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
- April 7, 1994
- Date Received
- November 12, 1992
- 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