Protectivstabilizer

FDA 510(k) K790186 · Jelco Laboratories

Substantially Equivalent

510(k) numberK790186

Submission

Device name
Protectivstabilizer
Applicant
Jelco Laboratories
Mchenry, IL, US
Received
January 29, 1979
Decision date
February 26, 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
K790946Gordon Ivs Intravenous StabilizerGBJ · Traditional Whitman Medical Corp.06/05/1979SE

More from Whitman Medical Corp.

510(k)DeviceDecision
K791918Jelco Winged Intravascular CatheterFOZ · Traditional 10/02/1979SE
K791372Jelco & Kvo Catheter Placement UnitJCY · Traditional 09/12/1979SE
K790967Catheter Metal Hub/RadiopaqueFOZ · Traditional 06/27/1979SE
K790968Catheter Metal Hub/NonradiopaqueFOZ · Traditional 06/11/1979SE
K790471Jelco* Disc FILTER-0.2 MicronFPB · Traditional 04/30/1979SE
K790107Catheter Tubing ModificationDQO · Traditional 02/01/1979SE
K790079Needle, Blood CollectingGAA · Traditional 02/01/1979SE
K781857Tray, Arterial Blood Gas SamplingCBT · Traditional 12/11/1978SE
K780896Needles, Design Change, IV CathetersGCB · Traditional 08/23/1978SE
K780519Filter TubeBSN · Traditional 05/09/1978SE

Questions and answers

When was Protectivstabilizer cleared by the FDA?

Protectivstabilizer (K790186) received a 510(k) decision of Substantially Equivalent on February 26, 1979, 28 days after the submission was received.

What is the product code of K790186?

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