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510(k) K843477

Device
PHARMA-PLAST RECTAL TIP
Applicant
ZIMMAR CONSULTING LTD.
510(k) number
K843477
Product code
FCF  
Decision
Substantially Equivalent (SESE)
Decision date
1984-12-05
Date received
1984-09-06
Regulation
876.1075
Classification name
Instrument, Biopsy, Mechanical, Gastrointestinal
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 FCF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K070759POWERED EZ-IO PEDIATRIC BONE MARROW ASPIRATION SYSTEMVidacare Corporation2007-05-21
K062833POWERED EZ-IO BONE MARROW ASPIRATION SYSTEMVidacare Corporation2006-11-30
K984168BARRETT'S ESOPHAGEAL CYTOLOGY DEVICEUnited States Endoscopy Group, Inc.1999-12-07
K915142AMCATH DISPOSABLE BIOPSY FORCEPSIntl. Medical, Inc.1992-01-10
K911155OVAL CUP BIOPSY FORCEPEndovations1991-08-07

Legacy Summary#

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FDA Review#

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