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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 K974083
Device Name CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKS
Applicant
OHMEDA MEDICAL
100 MOUNTAIN AVE.
MURRAY HILL,  NJ  07974 -2005
Applicant Contact JING ZHANG
Correspondent
OHMEDA MEDICAL
100 MOUNTAIN AVE.
MURRAY HILL,  NJ  07974 -2005
Correspondent Contact JING ZHANG
Regulation Number880.5440
Classification Product Code
FMG  
Date Received10/29/1997
Decision Date 01/13/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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