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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name chair, positioning, electric
510(k) Number K953342
Device Name TMR48
Applicant
PRIDE HEALTH CARE, INC.
259 WEST 6TH ST.
WEST WYOMING,  PA  18644
Applicant Contact GEORGE AMADEI
Correspondent
PRIDE HEALTH CARE, INC.
259 WEST 6TH ST.
WEST WYOMING,  PA  18644
Correspondent Contact GEORGE AMADEI
Regulation Number890.3110
Classification Product Code
INO  
Date Received07/11/1995
Decision Date 09/08/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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