510(k) K925930

MPC-150 MALE TO MALE LUER ADAPTER by Molded Products, Inc. — Product Code FPA

K925930 is an FDA 510(k) premarket notification submitted by Molded Products, Inc. for the device "MPC-150 MALE TO MALE LUER ADAPTER". The FDA issued a decision of Substantially Equivalent on August 16, 1993. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Molded Products, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 1993
Date Received
November 23, 1992
Clearance Type
Traditional
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