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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, Long-Term Greater Than 30 Days
510(k) Number K960055
Device Name MEDTRONIC PS MEDICAL BIOGLIDE VASCULAR CATHETER, SNGL LUMEN MODEL NOS 8960 & 8932
Applicant
PUDENZ-SCHULTE MEDICAL RESEARCH CORP.
UNIV BUSINESS CTR.
125 CREMONA DR.
GOLETA,  CA  93117
Applicant Contact TOM HOLDYCH
Correspondent
PUDENZ-SCHULTE MEDICAL RESEARCH CORP.
UNIV BUSINESS CTR.
125 CREMONA DR.
GOLETA,  CA  93117
Correspondent Contact TOM HOLDYCH
Regulation Number880.5970
Classification Product Code
LJS  
Date Received01/04/1996
Decision Date 09/30/1996
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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