Fork, Tuning BK-7519

FDA 510(k) K760303 · Fred Sammons, Inc.

Substantially Equivalent

510(k) numberK760303

Submission

Device name
Fork, Tuning BK-7519
Applicant
Fred Sammons, Inc.
Mchenry, IL, US
Received
July 23, 1976
Decision date
September 8, 1976
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GWX – Fork, Tuning
Device class
Class I (low risk)
Regulation
21 CFR 882.1525
Specialty
Neurology

Other 510(k)s with product code GWX

510(k)DeviceApplicantDecision
K874966Tuning ForksGWX · Traditional Solway, Inc.01/04/1988SE
K813304Conphar, Tuning ForksGWX · Traditional Conphar, Inc.12/10/1981SE
K761132Tuning ForkGWX · Traditional Fred Sammons, Inc.12/02/1976SE

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K831549Arm SlingsILI · Traditional 06/30/1983SE
K831548SplintsILH · Traditional 06/27/1983SE
K831550Finger Boniometer BK7506KQW · Traditional 06/24/1983SE
K831544Deluxe Traction Exercise Glove BK5035IOD · Traditional 06/24/1983SE
K831543Adjust. WEIGHTS-BK5171-05,10,20 BeokION · Traditional 06/24/1983SE
K831542Adjustable Polycentric Elbow HingeIQI · Traditional 06/24/1983SE
K831553Leg Drainage Bag Strap BK6011KNX · Traditional 06/16/1983SE
K831552Sorbothane Visco Inner Sole PadKNP · Traditional 06/08/1983SE

Questions and answers

When was Fork, Tuning BK-7519 cleared by the FDA?

Fork, Tuning BK-7519 (K760303) received a 510(k) decision of Substantially Equivalent on September 8, 1976, 47 days after the submission was received.

What is the product code of K760303?

The FDA product code is GWX – Fork, Tuning, a Class I (low risk) device regulated under 21 CFR 882.1525.