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510(k) K802007

Device
PEDIWET=GUAZE IMPREGNATED WITH PETROL
Applicant
POLLAK (INTL.), LTD.
510(k) number
K802007
Product code
FRQ  
Decision
Substantially Equivalent (SESE)
Decision date
1980-09-26
Date received
1980-08-20
Regulation
876.5980
Classification name
Tube, Levine
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FRQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K914887ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR/GASTRIC SUCTMallinckrodt Medical1992-05-08
K914530ICAN GT DRAINAGE BAGIcn Pharmaceuticals, Inc.1991-12-18

Legacy Summary#

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FDA Review#

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