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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Port & Catheter, Implanted, Subcutaneous, Intravascular
510(k) Number K930206
Device Name PS MEDICAL IPI ACCESS KIT
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 Number880.5965
Classification Product Code
LJT  
Date Received01/15/1993
Decision Date 02/25/1994
Decision Substantially Equivalent - Kit (SESK)
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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