510(k) K021296

SIMPLICITY QD EASY P INFUSION SET by Sterling Medivations, Inc. — Product Code FPA

K021296 is an FDA 510(k) premarket notification submitted by Sterling Medivations, Inc. for the device "SIMPLICITY QD EASY P INFUSION SET". The FDA issued a decision of Substantially Equivalent on May 14, 2002. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Sterling Medivations, Inc. has 26 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2002
Date Received
Apr 24, 2002
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type
510(k)

Source: FDA 510(k) database entry for K021296. Report a data issue: hello@regdatalab.com.