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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 K883764
Device Name INTRAVASCULAR ADMINISTRATION SET
Applicant
DEVICE LABS, INC.
3 INDUSTRIAL PARK RD.
MEDWAY,  MA  02053
Applicant Contact ELTON M TUCKER
Correspondent
DEVICE LABS, INC.
3 INDUSTRIAL PARK RD.
MEDWAY,  MA  02053
Correspondent Contact ELTON M TUCKER
Regulation Number880.5440
Classification Product Code
FPA  
Date Received09/06/1988
Decision Date 12/19/1988
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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