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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 K853019
Device Name NITROGLYCERIN INFUSION SET
Applicant
LYPHOMED, INC.
2045 NORTH CORNELL AVE.
MELROSE PARK,  IL  60160
Applicant Contact DIANE M KAMOS
Correspondent
LYPHOMED, INC.
2045 NORTH CORNELL AVE.
MELROSE PARK,  IL  60160
Correspondent Contact DIANE M KAMOS
Regulation Number880.5440
Classification Product Code
FPA  
Date Received07/17/1985
Decision Date 11/12/1985
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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