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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion
510(k) Number K922909
Device Name MEDICAL BATTERY PACKS
Applicant
ACCESS / GOD LOVES YOU
P.O. BOX 1630
CASTLE ROCK,  CO  80104
Applicant Contact GWEN REED
Correspondent
ACCESS / GOD LOVES YOU
P.O. BOX 1630
CASTLE ROCK,  CO  80104
Correspondent Contact GWEN REED
Regulation Number880.5725
Classification Product Code
FRN  
Date Received02/19/1992
Decision Date 09/23/1992
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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