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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name set, administration, intravascular
510(k) Number K781637
Device Name MODEL IV 1500 STANDARD BURETTE
Original Applicant
VALLEYLAB, INC.
Regulation Number880.5440
Classification Product Code
FPA  
Date Received09/21/1978
Decision Date 12/12/1978
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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