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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
Predetermined Change
Control Plan Authorized		 No
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