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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Disinfectant, Medical Devices
510(k) Number K870276
Device Name HEATED INSTRUMENT BATH
Applicant
Simpson/Basye, Inc.
430 Ayre St.
Wilmington,  DE  19804
Applicant Contact ROBERT A BASYE
Correspondent
Simpson/Basye, Inc.
430 Ayre St.
Wilmington,  DE  19804
Correspondent Contact ROBERT A BASYE
Regulation Number880.6890
Classification Product Code
LRJ  
Date Received01/27/1987
Decision Date 05/07/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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