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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Lamp, Infrared, Therapeutic Heating
510(k) Number K932881
Device Name OLYMPIC WARM-LAMP
Applicant
Olympic Medical Corp.
5900 First Ave. S.
Seattle,  WA  98108
Applicant Contact JOSEPH P STEFANILE
Correspondent
Olympic Medical Corp.
5900 First Ave. S.
Seattle,  WA  98108
Correspondent Contact JOSEPH P STEFANILE
Regulation Number890.5500
Classification Product Code
ILY  
Date Received06/14/1993
Decision Date 01/26/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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