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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Peritoneal
510(k) Number K854812
Device Name NELSON-JUNG PLEURAL CATH
Applicant
Research Medical, Inc.
1847 W. 2300 S.
Salt Lake City,  UT  84119
Applicant Contact MICHAEL N KELLY
Correspondent
Research Medical, Inc.
1847 W. 2300 S.
Salt Lake City,  UT  84119
Correspondent Contact MICHAEL N KELLY
Regulation Number878.4200
Classification Product Code
GBW  
Date Received12/03/1985
Decision Date 02/11/1986
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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