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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression
510(k) Number K134008
Device Name MD-FLEX HEAVY BODY
Applicant
Meta Biomed, Inc.
2600 Mullinix Mill Rd.
Mt. Airy,  MD  21771
Applicant Contact BLIX WINSTON
Correspondent
Meta Biomed, Inc.
2600 Mullinix Mill Rd.
Mt. Airy,  MD  21771
Correspondent Contact BLIX WINSTON
Regulation Number872.3660
Classification Product Code
ELW  
Date Received12/30/2013
Decision Date 04/09/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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