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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
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