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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Cartridge
510(k) Number K082249
Device Name MORPHEUS
Applicant
Meibach Tech Ltda
1740 Broadway
New York,  NY  10019
Applicant Contact STUART L FRIEDEL
Correspondent
Meibach Tech Ltda
1740 Broadway
New York,  NY  10019
Correspondent Contact STUART L FRIEDEL
Regulation Number872.6770
Classification Product Code
EJI  
Date Received08/08/2008
Decision Date 12/31/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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