510(k) K041779

NIPRO DISPOSABLE STOPCOCKS, MODELS 3W-RC. NCN-3, 3W-R, 3W-L by Nipro Medical Corp. — Product Code FMG

K041779 is an FDA 510(k) premarket notification submitted by Nipro Medical Corp. for the device "NIPRO DISPOSABLE STOPCOCKS, MODELS 3W-RC. NCN-3, 3W-R, 3W-L". The FDA issued a decision of Substantially Equivalent on September 21, 2004. The device falls under product code FMG (Stopcock, I.V. Set), a Class II device regulated under 21 CFR 880.5440. Nipro Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 2004
Date Received
July 1, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stopcock, I.V. Set
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type