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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 K862828
Device Name BSX BUCKY-STAND
Applicant
Garrels X-Ray Products, Inc.
3016 Central Ave.
P.O. Box 284
Ceres,  CA  95307
Applicant Contact DONALD GARRELS
Correspondent
Garrels X-Ray Products, Inc.
3016 Central Ave.
P.O. Box 284
Ceres,  CA  95307
Correspondent Contact DONALD GARRELS
Regulation Number892.1880
Classification Product Code
IXY  
Date Received07/25/1986
Decision Date 08/01/1986
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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