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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Holder, Radiographic Cassette, Wall-Mounted
510(k) Number K922443
Device Name VERT-X UNIVERSAL VERTICAL BUCKY STAND
Applicant
Afp Imaging Corp.
250 Clearbrook Rd.
Elmsford,  NY  10523
Applicant Contact RANDAL L HALE
Correspondent
Afp Imaging Corp.
250 Clearbrook Rd.
Elmsford,  NY  10523
Correspondent Contact RANDAL L HALE
Regulation Number892.1880
Classification Product Code
IXY  
Date Received05/22/1992
Decision Date 10/26/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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