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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pack, Heat, Moist
510(k) Number K790904
Device Name STAO-HOTPACK
Applicant
Staodynamics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Staodynamics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.5730
Classification Product Code
IMA  
Date Received05/11/1979
Decision Date 05/18/1979
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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