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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Shunt System Implantation
510(k) Number K930606
Device Name PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER
Applicant
PUDENZ-SCHULTE MEDICAL RESEARCH CORP.
125-B CREMONA DR.
GOLETA,  CA  93117
Applicant Contact TOM HOLDYCH
Correspondent
PUDENZ-SCHULTE MEDICAL RESEARCH CORP.
125-B CREMONA DR.
GOLETA,  CA  93117
Correspondent Contact TOM HOLDYCH
Regulation Number882.4545
Classification Product Code
GYK  
Date Received02/05/1993
Decision Date 09/10/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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