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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 K936178
Device Name AGILANCE-GOLDEN SPOONS
Applicant
Oismuller & Partner Keg
Maria Cebotari-Strabe 42
A-5020 Salzburg
Austria,  AT
Applicant Contact ANDREA PFAFFENBICHLER
Correspondent
Oismuller & Partner Keg
Maria Cebotari-Strabe 42
A-5020 Salzburg
Austria,  AT
Correspondent Contact ANDREA PFAFFENBICHLER
Regulation Number890.5660
Classification Product Code
ISA  
Date Received12/27/1993
Decision Date 01/18/1995
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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