510(k) K973652
K973652 is an FDA 510(k) premarket notification submitted by Scion International, Inc. for the device "DUOCLIPPER TITANIUM CLIPS". The FDA issued a decision of Substantially Equivalent on March 27, 1998. The device falls under product code FZP (Clip, Implantable), a Class II device regulated under 21 CFR 878.4300. Scion International, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 27, 1998
- Date Received
- September 25, 1997
- Clearance Type
- Traditional
- 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