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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, I.V.
510(k) Number K830299
Device Name SOLUTION TRANSFER CONTAINER
Applicant
The Healthcare Group Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
The Healthcare Group Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5025
Classification Product Code
KPE  
Date Received01/28/1983
Decision Date 02/19/1983
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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