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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 K850035
Device Name EMPTY SOLUTION TRANSFER CONTAINER
Applicant
The Healthcare Group Laboratories, Inc.
165 S. Mountain Way Dr.
Orem,  UT  84057
Applicant Contact PHIL RALSTON
Correspondent
The Healthcare Group Laboratories, Inc.
165 S. Mountain Way Dr.
Orem,  UT  84057
Correspondent Contact PHIL RALSTON
Regulation Number880.5025
Classification Product Code
KPE  
Date Received01/07/1985
Decision Date 06/07/1985
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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