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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 K872067
Device Name STERICAP ASSEMBLY AND REPLACEMENT TRAY
Applicant
Stericap Systems
1315 S. Glenburnie Rd.
Thomas Sq.
New Bern,  NC  28562
Applicant Contact PARHAM, MD
Correspondent
Stericap Systems
1315 S. Glenburnie Rd.
Thomas Sq.
New Bern,  NC  28562
Correspondent Contact PARHAM, MD
Regulation Number880.5440
Classification Product Code
FMG  
Date Received05/29/1987
Decision Date 08/04/1987
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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