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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Percussor, Powered-Electric
510(k) Number K100749
Device Name FREQUENCER MODEL V2X
Applicant
DYMEDSO INC.
127 MAIN ST.
SPRINGFIELD,  VT  05156 -0826
Applicant Contact Jean Bigoney
Correspondent
DYMEDSO INC.
127 MAIN ST.
SPRINGFIELD,  VT  05156 -0826
Correspondent Contact Jean Bigoney
Regulation Number868.5665
Classification Product Code
BYI  
Date Received03/16/2010
Decision Date 08/31/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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