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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 K952967
Device Name UNIMED MEDICAL DISPENSING PUMP
Applicant
A.Z.E. Medical, Inc.
1247 Florida Ave.
Palm Harobor,  FL  34683
Applicant Contact PATRICK J LAMB
Correspondent
A.Z.E. Medical, Inc.
1247 Florida Ave.
Palm Harobor,  FL  34683
Correspondent Contact PATRICK J LAMB
Regulation Number880.5725
Classification Product Code
FRN  
Date Received06/27/1995
Decision Date 02/09/1996
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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