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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, Intraventricular
510(k) Number K833822
Device Name P-S MEDICAL CSF ACCESS DEV 15MM/25MM
Applicant
Pudenz-Schulte Medical Research Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Pudenz-Schulte Medical Research Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number882.5550
Classification Product Code
LKG  
Date Received11/02/1983
Decision Date 05/25/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
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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