Tenet Mlti-Positioning Surgical Stirrup System

FDA 510(k) K963505 · Tenet Medical Engineering

Substantially Equivalent

510(k) numberK963505

Submission

Device name
Tenet Mlti-Positioning Surgical Stirrup System
Applicant
Tenet Medical Engineering
Calgary, CA
Received
September 3, 1996
Decision date
February 14, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
HHP – Table, Obstetrical, Manual (And Accessories)
Device class
Class II (moderate risk)
Regulation
21 CFR 884.4900
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code HHP

510(k)DeviceApplicantDecision
K822812Ysi Model 23L Lactate AnalyzerHHP · Traditional Yellow Springs Instrument Co., Inc.12/13/1982SE

More from Yellow Springs Instrument Co., Inc.

510(k)DeviceDecision
K963506Tenet Radiolucent Hand TableFQO · Traditional 01/09/1997SE
K964102Tenet Tibial Fracture SupportGBB · Traditional 12/05/1996SE

Questions and answers

When was Tenet Mlti-Positioning Surgical Stirrup System cleared by the FDA?

Tenet Mlti-Positioning Surgical Stirrup System (K963505) received a 510(k) decision of Substantially Equivalent on February 14, 1997, 164 days after the submission was received.

What is the product code of K963505?

The FDA product code is HHP – Table, Obstetrical, Manual (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.4900.