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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K914157
Device Name DRESSING/CVP DRESSING CHANGE/HYPERALIMENT TRAYS
Applicant
Cml, Inc.
P.O. Box 306
817 W. Mohr Ave.
Waterford,  WI  53185
Applicant Contact JOSEPH DUNN
Correspondent
Cml, Inc.
P.O. Box 306
817 W. Mohr Ave.
Waterford,  WI  53185
Correspondent Contact JOSEPH DUNN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received09/16/1991
Decision Date 12/13/1991
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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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