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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 K022816
Device Name W & H LISA STEAM STERILIZER
Applicant
A-Dec, Inc.
2601 Crestview Dr.
Newberg,  OR  97132 -9257
Applicant Contact TOM LOUISELL
Correspondent
A-Dec, Inc.
2601 Crestview Dr.
Newberg,  OR  97132 -9257
Correspondent Contact TOM LOUISELL
Regulation Number880.6880
Classification Product Code
FLE  
Date Received08/26/2002
Decision Date 02/07/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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