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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
Predetermined Change
Control Plan Authorized		 No
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