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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name powder, porcelain
510(k) Number K162677
Device Name L- OVC
Applicant
Rhondium, Ltd
4 Sheffield Street
katikati,  NZ 3129
Applicant Contact greer fricker
Correspondent
PaxMed International, LLC
12264 El Camino Real, Suite 400
san diego,  CA  92130
Correspondent Contact kevin a. thomas
Regulation Number872.6660
Classification Product Code
EIH  
Subsequent Product Codes
EBF   KLE  
Date Received09/26/2016
Decision Date 12/21/2016
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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