510(k) K902724

ADVANCE DISPOSABLE STOPCOCK by Advance Medical Designs, Inc. — Product Code FMG

K902724 is an FDA 510(k) premarket notification submitted by Advance Medical Designs, Inc. for the device "ADVANCE DISPOSABLE STOPCOCK". The FDA issued a decision of Substantially Equivalent on December 5, 1990. The device falls under product code FMG (Stopcock, I.V. Set), a Class II device regulated under 21 CFR 880.5440. Advance Medical Designs, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 1990
Date Received
June 21, 1990
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