510(k) K945225

DISPOSABLE SYRINGES AND DISPOSABLE NEEDLES by Myco Medical Supplies, Inc. — Product Code FMF

K945225 is an FDA 510(k) premarket notification submitted by Myco Medical Supplies, Inc. for the device "DISPOSABLE SYRINGES AND DISPOSABLE NEEDLES". The FDA issued a decision of Substantially Equivalent on January 26, 1995. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Myco Medical Supplies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1995
Date Received
October 26, 1994
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