510(k) K820384

GLASS SYRINGES, DRUG, LUER LOCK by Procedure Products, Inc. — Product Code FMF

K820384 is an FDA 510(k) premarket notification submitted by Procedure Products, Inc. for the device "GLASS SYRINGES, DRUG, LUER LOCK". The FDA issued a decision of Substantially Equivalent on April 15, 1982. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Procedure Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1982
Date Received
February 9, 1982
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