510(k) K905384
K905384 is an FDA 510(k) premarket notification submitted by Sparta Surgical Corp. for the device "DAVID SIMMONDS ANESTHESIA EXTENSION TUBES". The FDA issued a decision of Substantially Equivalent on March 22, 1991. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Sparta Surgical Corp. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 22, 1991
- Date Received
- November 29, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Syringe, Piston
- Device Class
- Class II
- Regulation Number
- 880.5860
- Review Panel
- HO
- Submission Type