510(k) K884589

FRANTZ MEDICAL SHARPS COLLECTOR by Franklin Medical USA, Inc. — Product Code FMF

K884589 is an FDA 510(k) premarket notification submitted by Franklin Medical USA, Inc. for the device "FRANTZ MEDICAL SHARPS COLLECTOR". The FDA issued a decision of Substantially Equivalent on December 9, 1988. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Franklin Medical USA, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1988
Date Received
November 3, 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