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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 K881805
Device Name TU STOPCOCK
Applicant
Tulan Corp. C/O Richard Hamer Assoc.
P.O. Box 1434
Sterling,  VA  22170
Applicant Contact RICHARD A HAMER
Correspondent
Tulan Corp. C/O Richard Hamer Assoc.
P.O. Box 1434
Sterling,  VA  22170
Correspondent Contact RICHARD A HAMER
Regulation Number880.5440
Classification Product Code
FMG  
Date Received04/28/1988
Decision Date 10/04/1988
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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