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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 K915667
Device Name MODEL H170 PEDIATRIC CHEST X-RAY UNIT
Applicant
H.L. Lyons Co.
11401 Electron Dr.
Louisville,  KY  40299
Applicant Contact LYONS
Correspondent
H.L. Lyons Co.
11401 Electron Dr.
Louisville,  KY  40299
Correspondent Contact LYONS
Regulation Number892.1880
Classification Product Code
IXY  
Date Received12/18/1991
Decision Date 01/31/1992
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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