510(k) K860040

HYDRAJUST III UROLOGICAL TABLE by Mallinckrodt Group, Inc. — Product Code KQS

K860040 is an FDA 510(k) premarket notification submitted by Mallinckrodt Group, Inc. for the device "HYDRAJUST III UROLOGICAL TABLE". The FDA issued a decision of Substantially Equivalent on February 10, 1986. The device falls under product code KQS (Table, Cystometric, Non-Electric And Accessories), a Class I device regulated under 21 CFR 876.4890. Mallinckrodt Group, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1986
Date Received
January 6, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Cystometric, Non-Electric And Accessories
Device Class
Class I
Regulation Number
876.4890
Review Panel
GU
Submission Type