510(k) K882329

L-F COILED EXTENSION TUBING by Mallinckrodt Group, Inc. — Product Code DXT

K882329 is an FDA 510(k) premarket notification submitted by Mallinckrodt Group, Inc. for the device "L-F COILED EXTENSION TUBING". The FDA issued a decision of Substantially Equivalent on September 2, 1988. The device falls under product code DXT (Injector And Syringe, Angiographic), a Class II device regulated under 21 CFR 870.1650. Mallinckrodt Group, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 1988
Date Received
June 6, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Injector And Syringe, Angiographic
Device Class
Class II
Regulation Number
870.1650
Review Panel
HO
Submission Type