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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Pump, Infusion
510(k) Number K023890
Device Name PREPARE CARTRIDGE
Applicant
Appro Healthcare, Inc.
847 Main St.
Buffalo,  NY  14203
Applicant Contact JOHN R SEMLER
Correspondent
Appro Healthcare, Inc.
847 Main St.
Buffalo,  NY  14203
Correspondent Contact JOHN R SEMLER
Regulation Number880.5725
Classification Product Code
MRZ  
Date Received11/21/2002
Decision Date 02/07/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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