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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K915468
Device Name MODEL P-81 CRITIKON PRINTER
Applicant
Critkon, Inc.
4110 George Rd.
P.O. Box 31800
Tampa,  FL  33631
Applicant Contact JOHN MATSON
Correspondent
Critkon, Inc.
4110 George Rd.
P.O. Box 31800
Tampa,  FL  33631
Correspondent Contact JOHN MATSON
Regulation Number870.1130
Classification Product Code
DXN  
Date Received12/05/1991
Decision Date 09/22/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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