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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, X-Ray, Extraoral With Timer
510(k) Number K122016
Device Name REXTAR, REXTAR LCD
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 Number872.1800
Classification Product Code
EHD  
Date Received07/10/2012
Decision Date 03/01/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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