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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, therapeutic, short-term less than 30 days
510(k) Number K223648
Device Name Cook® Spectrum® 2 MRC Central Venous Catheter
Applicant
Cook Advanced Technologies
1400 Cumberland Avenue
West Lafayette,  IN  47906
Applicant Contact Matthew Waninger
Correspondent
Cook Advanced Technologies
1400 Cumberland Avenue
West Lafayette,  IN  47906
Correspondent Contact Matthew Waninger
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received12/06/2022
Decision Date 02/03/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
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