FDA.reportPublic FDA data

510(k) K771733

Device
8 EMESIS BASIN
Applicant
Bemis Health Care
510(k) number
K771733
Product code
FNY
Decision
Substantially Equivalent (SESE)
Decision date
1977-09-28
Date received
1977-09-15
Regulation
880.6730
Classification name
Basin, Emesis
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Third party reviewed
N

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FNY#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K832826AAP DOSIMETRY RELEASE OR BASIN SETSAmerican Hospital Supply Corp.1984-04-23
K802538BASIN PACKTexas Medical Products, Inc.1980-10-31
K800440STERILE SPONGE BOWLSPremium Plastics, Inc.1980-04-29
K792625STERILIZATION PROCESS/PLACENTA BASINProcter & Gamble Mfg. Co.1980-01-16
K760492BASIN, LARGE OR SMALLLandmark Plastics1976-11-12
K760494BASIN, ROUND WASHLandmark Plastics1976-11-12
K760495BASIN, RECTANGULAR WASHLandmark Plastics1976-11-12
K760085BASIN, STERILE (#3200)Concord Laboratories, Inc.1976-07-20