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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 K851986
Device Name STOPCOCKS
Applicant
TRANSAMERICA DELAVAL, INC.
325 HALSTEAD ST.
P.O. BIN 7087
PASADENA,  CA  91109
Applicant Contact RICHARD G EKSTROM
Correspondent
TRANSAMERICA DELAVAL, INC.
325 HALSTEAD ST.
P.O. BIN 7087
PASADENA,  CA  91109
Correspondent Contact RICHARD G EKSTROM
Regulation Number880.5440
Classification Product Code
FMG  
Date Received05/07/1985
Decision Date 05/23/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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