Chick Surgical Table

FDA 510(k) K800118 · Warner-Lambert Co.

Substantially Equivalent

510(k) numberK800118

Submission

Device name
Chick Surgical Table
Applicant
Warner-Lambert Co.
Mchenry, IL, US
Received
January 18, 1980
Decision date
February 5, 1980
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FWY – Table, Operating-Room, Non-Electrical
Device class
Class I (low risk)
Regulation
21 CFR 878.4950
Specialty
General, Plastic Surgery

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K883457ASST-3000 Spinal Surgery TableFWY · Traditional Orthopedic Systems, Inc.08/26/1988SE
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K833509Chemonucleolysis TableFWY · Traditional Stryker Corp.11/28/1983SE

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Questions and answers

When was Chick Surgical Table cleared by the FDA?

Chick Surgical Table (K800118) received a 510(k) decision of Substantially Equivalent on February 5, 1980, 18 days after the submission was received.

What is the product code of K800118?

The FDA product code is FWY – Table, Operating-Room, Non-Electrical, a Class I (low risk) device regulated under 21 CFR 878.4950.