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510(k) K031114

Device
PRO-PACT PERACETIC ACID CULTURE TEST KIT, MODEL C-3PA
Applicant
RAVEN BIOLOGICAL LABORATORIES, INC.
510(k) number
K031114
Product code
MRB  
Decision
Substantially Equivalent (SESE)
Decision date
2004-03-03
Date received
2003-04-08
Regulation
880.2800
Classification name
Indicator, Biological, Liquid Chemical Sterilization Process
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
WENDY ROYALTY-HANN
Address
8607 Park Dr. Omaha NE US 68127 68127

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MRB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K081879SPSMEDICAL SPORVIEW PA CULTURE SETSpsmedical Supply Corp.2008-07-30
K053212RAVEN PROPACTRaven Biological Laboratories, Inc.2006-02-15
K043135SPSMEDICAL SPORVIEW PA CULTURE SETSpsmedical Supply Corp.2005-01-13

Legacy Summary#

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FDA Review#

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