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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion
510(k) Number K861324
Device Name PATIENTCARE 1000
Applicant
CRITICARE TECHNOLOGIES CORP.
1855 DEMING WAY
SPARKS,  NV  89431
Applicant Contact FRANK FERGUSON
Correspondent
CRITICARE TECHNOLOGIES CORP.
1855 DEMING WAY
SPARKS,  NV  89431
Correspondent Contact FRANK FERGUSON
Regulation Number880.5725
Classification Product Code
FRN  
Date Received04/08/1986
Decision Date 06/09/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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