510(k) K003283

SIMPLICITY WITH WINGS INFUSION SET, (MODEL MMT-103) by Sterling Medivations, Inc. — Product Code FPA

K003283 is an FDA 510(k) premarket notification submitted by Sterling Medivations, Inc. for the device "SIMPLICITY WITH WINGS INFUSION SET, (MODEL MMT-103)". The FDA issued a decision of Substantially Equivalent on Dec 13, 2000. 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
Dec 13, 2000
Date Received
Oct 19, 2000
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 K003283. Report a data issue: hello@regdatalab.com.