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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 K842678
Device Name I.V. TRANSFER SPIKE
Applicant
LYPHOMED, INC.
2020 RUBY ST.
MELROSE PARK,  IL  60160
Applicant Contact DILIP P SHAH
Correspondent
LYPHOMED, INC.
2020 RUBY ST.
MELROSE PARK,  IL  60160
Correspondent Contact DILIP P SHAH
Regulation Number880.5440
Classification Product Code
FPA  
Date Received07/10/1984
Decision Date 10/09/1984
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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