510(k) K951871
K951871 is an FDA 510(k) premarket notification submitted by Baxa Corp. for the device "PISTON SYRINGE". The FDA issued a decision of Substantially Equivalent on June 21, 1995. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Baxa Corp. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 21, 1995
- Date Received
- April 21, 1995
- 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