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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name disinfector, medical devices
510(k) Number K081094
Device Name OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500
Applicant
OLYMPIC MEDICAL CORP.
5900 FIRST AVE., SOUTH
SEATTLE,  WA  98108
Applicant Contact STEVE HESLER
Correspondent
OLYMPIC MEDICAL CORP.
5900 FIRST AVE., SOUTH
SEATTLE,  WA  98108
Correspondent Contact STEVE HESLER
Regulation Number880.6992
Classification Product Code
MEC  
Date Received04/17/2008
Decision Date 06/20/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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