510(k) K882723
K882723 is an FDA 510(k) premarket notification submitted by Alcon Laboratories for the device "ALCON FLUID INJECTOR". The FDA issued a decision of Substantially Equivalent on November 8, 1988. The device falls under product code DQF (Actuator, Syringe, Injector Type), a Class II device regulated under 21 CFR 870.1670. Alcon Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 8, 1988
- Date Received
- July 1, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Actuator, Syringe, Injector Type
- Device Class
- Class II
- Regulation Number
- 870.1670
- Review Panel
- HO
- Submission Type