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510(k) K802538

Device
BASIN PACK
Applicant
TEXAS MEDICAL PRODUCTS, INC.
510(k) number
K802538
Product code
FNY  
Decision
Substantially Equivalent (SESE)
Decision date
1980-10-31
Date received
1980-10-15
Regulation
880.6730
Classification name
Basin, Emesis
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Third party reviewed
No

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
K800440STERILE SPONGE BOWLSPremium Plastics, Inc.1980-04-29
K792625STERILIZATION PROCESS/PLACENTA BASINProcter & Gamble Mfg. Co.1980-01-16
K7717338 EMESIS BASINBemis Health Care1977-09-28
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

Legacy Summary#

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FDA Review#

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