Medicine Cup

FDA 510(k) K791345 · General Clinical Plastics Corp.

Substantially Equivalent

510(k) numberK791345

Submission

Device name
Medicine Cup
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
KYW – Container, Liquid Medication, Graduated
Device class
Class I (low risk)
Regulation
21 CFR 880.6430
Specialty
General Hospital

Other 510(k)s with product code KYW

510(k)DeviceApplicantDecision
K800213Pharmacy Additive Syringe SetKYW · Traditional Cutter Laboratories, Inc.02/26/1980SE

More from Cutter Laboratories, Inc.

510(k)DeviceDecision
K792211Speciman Cup & Emesis BasinFMH · Traditional 11/16/1979SE
K791348Round Washbasin & Rectangle Washbasin · Traditional 09/17/1979SE
K791346Disposable BedpanFOB · Traditional 08/03/1979SE

Questions and answers

When was Medicine Cup cleared by the FDA?

Medicine Cup (K791345) 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 K791345?

The FDA product code is KYW – Container, Liquid Medication, Graduated, a Class I (low risk) device regulated under 21 CFR 880.6430.