510(k) K071630

TERUMO 31G THINPRO INSULIN SYRINGE by Terumo Medical Corp. — Product Code FMF

K071630 is an FDA 510(k) premarket notification submitted by Terumo Medical Corp. for the device "TERUMO 31G THINPRO INSULIN SYRINGE". The FDA issued a decision of Substantially Equivalent on July 11, 2007. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Terumo Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2007
Date Received
June 14, 2007
Clearance Type
Special
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