510(k) K800118
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