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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrosurgical, cutting & coagulation & accessories
510(k) Number K102698
Model PELLEVE GLIDESAFE
Device Name PELLEVE GLIDESAFE NON-ABLATIVE WRINKLE TREATMENT SYSTEM MODEL PELLEVE GLIDESAFE
Original Applicant
ELLMAN INT'L INC.
3333 royal avenue
oceanside,  NY  11572 3625
Original Contact jonathan achenbach
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/20/2010
Decision Date 01/05/2011
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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