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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scale, Patient
510(k) Number K926446
Device Name EZ PUMP
Applicant
Alphamed, Inc.
Post Office Box 550
Duluth,  GA  30136
Applicant Contact DAVID AMMANN
Correspondent
Alphamed, Inc.
Post Office Box 550
Duluth,  GA  30136
Correspondent Contact DAVID AMMANN
Regulation Number880.2720
Classification Product Code
FRW  
Date Received12/23/1992
Decision Date 09/27/1993
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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