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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 K972527
Device Name PHASEAL, SYSTEM FOR SEALED HANDLING OF CHEMOTHERAPEUTIC AGENTS
Applicant
Quality System Consulting
1425 Cressa Court
Carlsbad,  CA  92009
Applicant Contact FRED SCHLADOR
Correspondent
Quality System Consulting
1425 Cressa Court
Carlsbad,  CA  92009
Correspondent Contact FRED SCHLADOR
Regulation Number880.5440
Classification Product Code
FPA  
Date Received07/07/1997
Decision Date 09/18/1997
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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