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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K951682
Device Name OCTOSTIM
Applicant
Freiler
1940 17th Ave.
Santa Cruz,  CA  95062
Applicant Contact TAKASHI YOGI
Correspondent
Freiler
1940 17th Ave.
Santa Cruz,  CA  95062
Correspondent Contact TAKASHI YOGI
Regulation Number890.5850
Classification Product Code
IPF  
Date Received04/11/1995
Decision Date 12/11/1995
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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