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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
Predetermined Change
Control Plan Authorized		 No
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