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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Patient Examination Glove
510(k) Number K831964
Device Name CMS 2000 SERIES TPN KITS
Applicant
Currie Medical Specialties, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Currie Medical Specialties, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.6250
Classification Product Code
FMC  
Date Received06/17/1983
Decision Date 08/11/1983
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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