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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 K082568
Device Name SALINE ENHANCED ELECTROSURGICAL RESECTION (SEER) DEVICE
Applicant
BOVIE MEDICAL
7100 30th ave. north
st. petersburg,  FL  33710 2902
Contact richard a kozloff
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/04/2008
Decision Date 11/17/2008
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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