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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name I.V. Start Kit
510(k) Number K924538
Device Name IV START KIT
Applicant
CML, INC.
P.O. BOX 306
817 W. MOHR AVENUE
WATERFORD,  WI  53185
Applicant Contact JOSEPH DUNN
Correspondent
CML, INC.
P.O. BOX 306
817 W. MOHR AVENUE
WATERFORD,  WI  53185
Correspondent Contact JOSEPH DUNN
Regulation Number880.5200
Classification Product Code
LRS  
Date Received09/08/1992
Decision Date 07/02/1993
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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