510(k) K810921

MALE LUER LOCK PLUGS by Procedure Products, Inc. — Product Code FPA

K810921 is an FDA 510(k) premarket notification submitted by Procedure Products, Inc. for the device "MALE LUER LOCK PLUGS". The FDA issued a decision of Substantially Equivalent on May 21, 1981. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Procedure Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 1981
Date Received
April 6, 1981
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