The following data is part of a premarket notification filed by General Clinical Plastics Corp. with the FDA for Medicine Cup.
Device ID | K791345 |
510k Number | K791345 |
Device Name: | MEDICINE CUP |
Classification | Container, Liquid Medication, Graduated |
Applicant | GENERAL CLINICAL PLASTICS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KYW |
CFR Regulation Number | 880.6430 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-07-12 |
Decision Date | 1979-08-03 |