510(k) K800118

CHICK SURGICAL TABLE by Warner-Lambert Co. — Product Code FWY

K800118 is an FDA 510(k) premarket notification submitted by Warner-Lambert Co. for the device "CHICK SURGICAL TABLE". The FDA issued a decision of Substantially Equivalent on February 5, 1980. The device falls under product code FWY (Table, Operating-Room, Non-Electrical), a Class I device regulated under 21 CFR 878.4950. Warner-Lambert Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 1980
Date Received
January 18, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Operating-Room, Non-Electrical
Device Class
Class I
Regulation Number
878.4950
Review Panel
SU
Submission Type