510(k) K172479
K172479 is an FDA 510(k) premarket notification submitted by Amsel Medical for the device "Amsel Occluder Device". The FDA issued a decision of Substantially Equivalent on Sep 14, 2017. The device falls under product code FZP (Clip, Implantable), a Class II device regulated under 21 CFR 878.4300.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 14, 2017
- Date Received
- Aug 16, 2017
- 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
- 510(k)