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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 K850047
Device Name SANYO ELECTRONIC MUSCLE STIMULATORS
Applicant
General Physiotherapy, Inc.
1520 Washington Ave.
St. Louis,  MO  63103
Applicant Contact JOSEPH J LEYDON
Correspondent
General Physiotherapy, Inc.
1520 Washington Ave.
St. Louis,  MO  63103
Correspondent Contact JOSEPH J LEYDON
Regulation Number890.5850
Classification Product Code
IPF  
Date Received01/08/1985
Decision Date 03/05/1985
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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