510(k) K895369
K895369 is an FDA 510(k) premarket notification submitted by Voss Medical Products for the device "VOSS GRAFT MARKER". The FDA issued a decision of Substantially Equivalent on September 27, 1989. The device falls under product code KPK (Marker, Ostia, Aorto-Saphenous Vein), a Class II device regulated under 21 CFR 878.4650. Voss Medical Products has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 27, 1989
- Date Received
- August 29, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Marker, Ostia, Aorto-Saphenous Vein
- Device Class
- Class II
- Regulation Number
- 878.4650
- Review Panel
- CV
- Submission Type