Gordon Ivs Intravenous Stabilizer

FDA 510(k) K790946 · Whitman Medical Corp.

Substantially Equivalent

510(k) numberK790946

Submission

Device name
Gordon Ivs Intravenous Stabilizer
Applicant
Whitman Medical Corp.
Mchenry, IL, US
Received
May 18, 1979
Decision date
June 5, 1979
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GBJ – Prosthesis, Adhesive, External
Device class
Class I (low risk)
Regulation
21 CFR 878.3750
Specialty
General, Plastic Surgery

Other 510(k)s with product code GBJ

510(k)DeviceApplicantDecision
K934970DuetGBJ · Traditional Trulife , Ltd.12/10/1993SE
K810282Operating Table Accessory ClampGBJ · Traditional Minnesota Scientific, Inc.02/26/1981SE
K790186ProtectivstabilizerGBJ · Traditional Jelco Laboratories02/26/1979SE

Questions and answers

When was Gordon Ivs Intravenous Stabilizer cleared by the FDA?

Gordon Ivs Intravenous Stabilizer (K790946) received a 510(k) decision of Substantially Equivalent on June 5, 1979, 18 days after the submission was received.

What is the product code of K790946?

The FDA product code is GBJ – Prosthesis, Adhesive, External, a Class I (low risk) device regulated under 21 CFR 878.3750.