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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 K042129
Device Name F00010 - IV GRAVITY SETWITH MALE LUER SLIP; F00027 - IV GRAVITY SET WITH MALE LUER LOCK
Applicant
Cedic S.R.L.
Via Liberazione, 63/9
Peschiera Borromeo,  IT 20068
Applicant Contact GIANCARLO GAGLIARDONI
Correspondent
Cedic S.R.L.
Via Liberazione, 63/9
Peschiera Borromeo,  IT 20068
Correspondent Contact GIANCARLO GAGLIARDONI
Regulation Number880.5440
Classification Product Code
FPA  
Date Received08/06/2004
Decision Date 01/27/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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