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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 K923448
Device Name EMPTY SOLUTION TRANSFER CONTAINER W/ DETACH LEG
Applicant
Healthtek, Inc.
12919 Earhart Ave.
Auburn,  CA  95602
Applicant Contact ROGER MOLINA
Correspondent
Healthtek, Inc.
12919 Earhart Ave.
Auburn,  CA  95602
Correspondent Contact ROGER MOLINA
Regulation Number880.5025
Classification Product Code
KPE  
Subsequent Product Code
LHI  
Date Received07/14/1992
Decision Date 07/28/1993
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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