510(k) K861561
K861561 is an FDA 510(k) premarket notification submitted by Zest Anchors, Inc. for the device "ZEST MARK II (STANDARD & MINI)". The FDA issued a decision of Substantially Equivalent on May 21, 1986. 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
- May 21, 1986
- Date Received
- April 25, 1986
- 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