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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Cabinet, X-Ray System
510(k) Number K091928
Device Name 10 X 10 VISION
Applicant
BIOPTICS, INC.
3440 E BRITANNIA DR
SUITE 150
TUCSON,  AZ  85743
Applicant Contact AKIF BAYSAL
Correspondent
BIOPTICS, INC.
3440 E BRITANNIA DR
SUITE 150
TUCSON,  AZ  85743
Correspondent Contact AKIF BAYSAL
Regulation Number892.1680
Classification Product Code
MWP  
Date Received06/30/2009
Decision Date 06/16/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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