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510(k) K962649

Device
SPORTROL RAPID STERILITY INDICATOR
Applicant
NORTH AMERICAN SCIENCE ASSOC., INC.
510(k) number
K962649
Product code
MTC  
Decision
Substantially Equivalent (SESE)
Decision date
1997-09-26
Date received
1996-07-08
Regulation
880.2800
Classification name
Indicator, Chemical, Enzymatic, 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
MATTHEW SLIVA
Address
2261 Tracy Rd. Northwood OH US 43619 43619

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MTC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K210481Instant 20s IndicatorTrue Indicating, LLC2021-12-14

Legacy Summary#

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FDA Review#

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