510(k) K963006
K963006 is an FDA 510(k) premarket notification submitted by Scion International, Inc. for the device "SCION SAPHENOUS VEIN HARVESTING SYSTEM". The FDA issued a decision of Substantially Equivalent on September 20, 1996. The device falls under product code GAD (Retractor), a Class I device regulated under 21 CFR 878.4800. Scion International, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 20, 1996
- Date Received
- August 2, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Retractor
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type