510(k) K791699

HYDRADJUST II UROLOGICAL TABLE by Sybron Corp. — Product Code KQS

K791699 is an FDA 510(k) premarket notification submitted by Sybron Corp. for the device "HYDRADJUST II UROLOGICAL TABLE". The FDA issued a decision of Substantially Equivalent on October 22, 1979. The device falls under product code KQS (Table, Cystometric, Non-Electric And Accessories), a Class I device regulated under 21 CFR 876.4890. Sybron Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 1979
Date Received
August 29, 1979
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