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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 K880260
Device Name SAFECATH
Applicant
PHASE MEDICAL SYSTEMS, INC.
3613 W. MACARTHUR BLVD.
SUITE 612
SANTA ANA,  CA  92704
Applicant Contact WALTER E COVER
Correspondent
PHASE MEDICAL SYSTEMS, INC.
3613 W. MACARTHUR BLVD.
SUITE 612
SANTA ANA,  CA  92704
Correspondent Contact WALTER E COVER
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received01/22/1988
Decision Date 04/19/1988
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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