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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Holder, Head, Radiographic
510(k) Number K850197
Device Name KELLER CEPHALOMETRIC DEVICE
Applicant
Gary D. Keller
Grayson Bank Bldg.
Suite 201 - 400 N.
Sherman,  TX  75090
Correspondent
Gary D. Keller
Grayson Bank Bldg.
Suite 201 - 400 N.
Sherman,  TX  75090
Regulation Number892.1920
Classification Product Code
IWY  
Date Received01/18/1985
Decision Date 03/22/1985
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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