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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilizer, Steam
510(k) Number K014174
Device Name HARVEY PV DRY STERILIZER, MODEL # ST127325; ST127320; ST127320-33
Applicant
Barnstead/Thermolyne Corp.
P.O. Box 797
Dubuque,  IA  52001
Applicant Contact MIA M WARE
Correspondent
Tuv Rheinland of North America, Inc.
12 Commerce Rd.
Newton,  CT  06470
Correspondent Contact REINER KRUMME
Regulation Number880.6880
Classification Product Code
FLE  
Date Received12/20/2001
Decision Date 02/22/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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