510(k) K882723

ALCON FLUID INJECTOR by Alcon Laboratories — Product Code DQF

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