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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stopcock, I.V. Set
510(k) Number K860889
Device Name SAMPLE MANIFOLD HOLDER
Applicant
R. Bell
5 Sanderling
Irvine,  CA  92714
Applicant Contact LINDA L BELL
Correspondent
R. Bell
5 Sanderling
Irvine,  CA  92714
Correspondent Contact LINDA L BELL
Regulation Number880.5440
Classification Product Code
FMG  
Date Received03/10/1986
Decision Date 04/07/1986
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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