510(k) K791645
K791645 is an FDA 510(k) premarket notification submitted by Vickers America Medical Corp. for the device "VICKERS MEDICAL MODEL 112 TREONIC DC2". The FDA issued a decision of Substantially Equivalent on October 2, 1979. The device falls under product code FKW (Tip, Vessel), a Class II device regulated under 21 CFR 876.5540. Vickers America Medical Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 2, 1979
- Date Received
- August 23, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tip, Vessel
- Device Class
- Class II
- Regulation Number
- 876.5540
- Review Panel
- GU
- Submission Type