Disposable Bedpan

FDA 510(k) K791346 · General Clinical Plastics Corp.

Substantially Equivalent

510(k) numberK791346

Submission

Device name
Disposable Bedpan
Applicant
General Clinical Plastics Corp.
Mchenry, IL, US
Received
July 12, 1979
Decision date
August 3, 1979
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FOB – Bedpan
Device class
Class I (low risk)
Regulation
21 CFR 880.6730
Specialty
General Hospital

Other 510(k)s with product code FOB

510(k)DeviceApplicantDecision
K780370Stand Up ToiletFOB · Traditional Medical Specialty Products, Inc.04/10/1978SE
K760490Bedpan, General Medical Medi-PakFOB · Traditional Landmark Plastics11/12/1976SE
K760393Bed Pan, Stackable (Autoclavable)FOB · Traditional Bemis Health Care08/23/1976SE
K760307Bedpan, Single Patient Use, TecnolFOB · Traditional Tecnol New Jersey Wound Care, Inc.08/11/1976SE

More from Tecnol New Jersey Wound Care, Inc.

510(k)DeviceDecision
K792211Speciman Cup & Emesis BasinFMH · Traditional 11/16/1979SE
K791348Round Washbasin & Rectangle Washbasin · Traditional 09/17/1979SE
K791345Medicine CupKYW · Traditional 08/03/1979SE

Questions and answers

When was Disposable Bedpan cleared by the FDA?

Disposable Bedpan (K791346) received a 510(k) decision of Substantially Equivalent on August 3, 1979, 22 days after the submission was received.

What is the product code of K791346?

The FDA product code is FOB – Bedpan, a Class I (low risk) device regulated under 21 CFR 880.6730.