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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 K960764
Device Name SAFE-CATH
Applicant
Scientific Device Manufacturer, LLC
999 Andersen Dr., Suite 120
San Rafael,  CA  94901
Applicant Contact RICHARD C BELL
Correspondent
Scientific Device Manufacturer, LLC
999 Andersen Dr., Suite 120
San Rafael,  CA  94901
Correspondent Contact RICHARD C BELL
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received02/26/1996
Decision Date 04/24/1997
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 No
Predetermined Change
Control Plan Authorized		 No
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