510(k) K882403

OPHTHALMIC FLUID INJECTOR by Trek Medical Products, Inc. — Product Code FMF

K882403 is an FDA 510(k) premarket notification submitted by Trek Medical Products, Inc. for the device "OPHTHALMIC FLUID INJECTOR". The FDA issued a decision of Substantially Equivalent on September 9, 1988. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Trek Medical Products, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1988
Date Received
June 10, 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