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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cabinet, Moist Steam
510(k) Number K914234
Device Name SAUNETTE, PORTABLE STEAM CABIN
Applicant
Sauna Magic, Inc.
5500 Tomken Rd., Unit #9
Mississauga, Ontario,  CA L4W 2Z4
Applicant Contact INDRA SOOGRIM
Correspondent
Sauna Magic, Inc.
5500 Tomken Rd., Unit #9
Mississauga, Ontario,  CA L4W 2Z4
Correspondent Contact INDRA SOOGRIM
Regulation Number890.5250
Classification Product Code
IMB  
Date Received09/20/1991
Decision Date 02/11/1992
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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