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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pack, Hot Or Cold, Reusable
510(k) Number K905207
Device Name MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS
Applicant
Micro Surgical Instruments Corp.
24971 Ave. Stanford W.
Valencia,  CA  91355
Applicant Contact MOE KHOSRAVI
Correspondent
Micro Surgical Instruments Corp.
24971 Ave. Stanford W.
Valencia,  CA  91355
Correspondent Contact MOE KHOSRAVI
Regulation Number890.5700
Classification Product Code
IME  
Date Received11/20/1990
Decision Date 01/22/1991
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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