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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 K940621
Device Name PRO-SHIATSU PORTABLE MASSAGER
Applicant
Westminster International Co., Inc.
436 Armour Cir.,NE
Atlanta,  GA  30324
Applicant Contact MAX K SEYMER
Correspondent
Westminster International Co., Inc.
436 Armour Cir.,NE
Atlanta,  GA  30324
Correspondent Contact MAX K SEYMER
Regulation Number890.5660
Classification Product Code
ISA  
Date Received02/14/1994
Decision Date 06/22/1994
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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