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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chair, With Casters
510(k) Number K925247
Device Name STONEHEART ROLLER AID
Applicant
Stoneheart, Inc.
224 2nd St., Box 329
Cheney,  WA  99004
Applicant Contact HEATHER STONE
Correspondent
Stoneheart, Inc.
224 2nd St., Box 329
Cheney,  WA  99004
Correspondent Contact HEATHER STONE
Regulation Number890.3100
Classification Product Code
INM  
Date Received10/16/1992
Decision Date 02/12/1993
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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