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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 K792125
Device Name 3&4 WAY PLASTIC STOPCOCKS, NONSTERILE
Applicant
TRONOMED, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Applicant Contact Andrew Harautuneian
Correspondent
TRONOMED, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent Contact Andrew Harautuneian
Regulation Number880.5440
Classification Product Code
FMG  
Date Received10/24/1979
Decision Date 01/16/1980
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
Recalls CDRH Recalls
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