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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Exerciser, Measuring
510(k) Number K940065
Device Name SES100
Applicant
Southwest Ergonomics
1448 Halsey Way
Suite 108
Carrollton,  TX  75007
Applicant Contact LARRY MCBRYDE
Correspondent
Southwest Ergonomics
1448 Halsey Way
Suite 108
Carrollton,  TX  75007
Correspondent Contact LARRY MCBRYDE
Regulation Number890.5360
Classification Product Code
ISD  
Date Received01/06/1994
Decision Date 12/06/1994
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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