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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
510(k) Number K853099
Device Name L.O.N. PRES MON LINES, CPC LINES, ADMINISTRATION
Applicant
L.O.N. Research, Inc.
709 Commerce Cir.
Longwood,  FL  32750
Applicant Contact DE PEDRO
Correspondent
L.O.N. Research, Inc.
709 Commerce Cir.
Longwood,  FL  32750
Correspondent Contact DE PEDRO
Regulation Number870.4290
Classification Product Code
DTL  
Date Received07/23/1985
Decision Date 12/03/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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