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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter And Tip, Suction
510(k) Number K864937
Device Name 'EXMOOR' ZOELLNER SUCKER ENDS
Applicant
Exmoor Plastics , Ltd.
Lisieux Way
Taunton,  GB TA1 2LB
Applicant Contact BRIAN EAST
Correspondent
Exmoor Plastics , Ltd.
Lisieux Way
Taunton,  GB TA1 2LB
Correspondent Contact BRIAN EAST
Regulation Number880.6740
Classification Product Code
JOL  
Date Received12/16/1986
Decision Date 03/30/1987
Decision Substantially Equivalent (SESE)
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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