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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Irrigation
510(k) Number K844876
Device Name PENNINE NELATON CATHETERS SIZES 5,6,8,10,12,14,16,
Applicant
Pennine Medical , Ltd.
Pontefract St.Ascot
Dr.Ind.Esate
Derby,  GB
Applicant Contact TERRY MORGAN
Correspondent
Pennine Medical , Ltd.
Pontefract St.Ascot
Dr.Ind.Esate
Derby,  GB
Correspondent Contact TERRY MORGAN
Regulation Number878.4200
Classification Product Code
GBX  
Date Received12/17/1984
Decision Date 06/05/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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