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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Therapeutic, Electric
510(k) Number K853297
Device Name MULTIPLE
Applicant
Sun Air, Inc.
1-7, Akasaka, 9-Chome,
Minato-Ku
Tokyo,  JP 201-0057
Applicant Contact TAKASHI TSUMURA
Correspondent
Sun Air, Inc.
1-7, Akasaka, 9-Chome,
Minato-Ku
Tokyo,  JP 201-0057
Correspondent Contact TAKASHI TSUMURA
Regulation Number890.5660
Classification Product Code
ISA  
Date Received08/06/1985
Decision Date 11/05/1985
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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