510(k) K893766

LIFECARE CONT. EPIDURAL CATH. FOR MORPHINE SULFATE by Abbott Laboratories — Product Code MAJ

K893766 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "LIFECARE CONT. EPIDURAL CATH. FOR MORPHINE SULFATE". The FDA issued a decision of Substantially Equivalent on November 1, 1989. The device falls under product code MAJ (Catheter, Percutaneous, Intraspinal, Short Term), a Class II device regulated under 21 CFR 868.5120. Abbott Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 1989
Date Received
May 19, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous, Intraspinal, Short Term
Device Class
Class II
Regulation Number
868.5120
Review Panel
HO
Submission Type