510(k) K072525
K072525 is an FDA 510(k) premarket notification submitted by Medicinelodge, Inc. for the device "ZIPKNOT, MODEL 1017-3000". The FDA issued a decision of Substantially Equivalent on October 5, 2007. The device falls under product code FZP (Clip, Implantable), a Class II device regulated under 21 CFR 878.4300. Medicinelodge, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 5, 2007
- Date Received
- September 7, 2007
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clip, Implantable
- Device Class
- Class II
- Regulation Number
- 878.4300
- Review Panel
- SU
- Submission Type