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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Vessel, For Percutaneous Catheterization
510(k) Number K960917
Device Name PERCUGLIDE
Applicant
Scientific Device Manufacturer, LLC
999 Andersen Dr., Suite 120
San Rafael,  CA  94901
Applicant Contact RICHARD C BALL
Correspondent
Scientific Device Manufacturer, LLC
999 Andersen Dr., Suite 120
San Rafael,  CA  94901
Correspondent Contact RICHARD C BALL
Regulation Number870.1310
Classification Product Code
DRE  
Date Received03/06/1996
Decision Date 07/02/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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