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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K023769
Device Name PREPARE ADMINISTRATION SET
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 Number880.5440
Classification Product Code
FPA  
Date Received11/12/2002
Decision Date 12/30/2002
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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