510(k) K884233
K884233 is an FDA 510(k) premarket notification submitted by Ellis Pharmaceutical Consulting, Inc. for the device "QUADROJECT(TM)". The FDA issued a decision of Substantially Equivalent on January 30, 1989. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Ellis Pharmaceutical Consulting, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 30, 1989
- Date Received
- October 7, 1988
- 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