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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Powered
510(k) Number K944423
Device Name POWER RECLINER
Applicant
Sunrise Medical, Inc.
2842 Business Park Ave.
Fresno,  CA  93727
Applicant Contact PAT SPINK
Correspondent
Sunrise Medical, Inc.
2842 Business Park Ave.
Fresno,  CA  93727
Correspondent Contact PAT SPINK
Regulation Number890.3860
Classification Product Code
ITI  
Date Received08/31/1994
Decision Date 11/28/1994
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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