510(k) K940070

STOPCOCK INTRAVENOUS THERAPY by Puritas Health Care, Inc. — Product Code FMG

K940070 is an FDA 510(k) premarket notification submitted by Puritas Health Care, Inc. for the device "STOPCOCK INTRAVENOUS THERAPY". The FDA issued a decision of Substantially Equivalent on April 4, 1994. The device falls under product code FMG (Stopcock, I.V. Set), a Class II device regulated under 21 CFR 880.5440. Puritas Health Care, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1994
Date Received
January 6, 1994
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