The following data is part of a premarket notification filed by General Clinical Plastics Corp. with the FDA for Speciman Cup & Emesis Basin.
Device ID | K792211 |
510k Number | K792211 |
Device Name: | SPECIMAN CUP & EMESIS BASIN |
Classification | Container, Specimen, Sterile |
Applicant | GENERAL CLINICAL PLASTICS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FMH |
CFR Regulation Number | 864.3250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-11-02 |
Decision Date | 1979-11-16 |