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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 K830972
Device Name I.V. CATHETER PLACEMENT UNIT POLYURETH
Applicant
CRITIKON COMPANY,LLC
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
CRITIKON COMPANY,LLC
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received03/28/1983
Decision Date 04/27/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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