510(k) K900857

NON STERILE PARENTERAL SUPPLY KIT by Intermed, Inc. — Product Code FMF

K900857 is an FDA 510(k) premarket notification submitted by Intermed, Inc. for the device "NON STERILE PARENTERAL SUPPLY KIT". The FDA issued a decision of Substantially Equivalent (kit, denovo) on May 22, 1990. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Intermed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
May 22, 1990
Date Received
February 23, 1990
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