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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Controller, Foot, Handpiece And Cord
510(k) Number K790322
Device Name OPTIONAL ACCESSORY FOOT SWITCH MODEL 100
Applicant
Applied Medical Research
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Applied Medical Research
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number872.4200
Classification Product Code
EBW  
Date Received02/15/1979
Decision Date 05/14/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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