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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 K884657
Device Name LILY I.V. SET
Applicant
Modec Co., Inc.
405b Reynolds Cir.
San Jose,  CA  95112
Applicant Contact EDDIE FONG
Correspondent
Modec Co., Inc.
405b Reynolds Cir.
San Jose,  CA  95112
Correspondent Contact EDDIE FONG
Regulation Number880.5440
Classification Product Code
FPA  
Date Received11/07/1988
Decision Date 03/22/1989
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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