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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope, Neurological
510(k) Number K940096
Device Name PS MEDICAL CATHETER PLACEMENT KIT
Applicant
Pudenz-Schulte Medical Research Corp.
University Business Center
125-B Cremona Dr.
Goleta,  CA  93117
Applicant Contact TOM HOLDYCH
Correspondent
Pudenz-Schulte Medical Research Corp.
University Business Center
125-B Cremona Dr.
Goleta,  CA  93117
Correspondent Contact TOM HOLDYCH
Regulation Number882.1480
Classification Product Code
GWG  
Date Received01/07/1994
Decision Date 05/03/1994
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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