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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pad, Heating, Powered
510(k) Number K922089
Device Name PNEUMATHERM
Applicant
NATIONAL PAIN INSTITUTE
7677 CENTER AVE.
HUNTINGTON BEACH,  CA  92647
Applicant Contact BRUCE FROME
Correspondent
NATIONAL PAIN INSTITUTE
7677 CENTER AVE.
HUNTINGTON BEACH,  CA  92647
Correspondent Contact BRUCE FROME
Regulation Number890.5740
Classification Product Code
IRT  
Date Received05/04/1992
Decision Date 02/23/1993
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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