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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assembly, Tube Housing, X-Ray, Diagnostic
510(k) Number K873314
Device Name TOSHIBA, SMIT ROENTGEN
Applicant
Inland Tube Corp.
4629 Biston St.
Boca Raton,  FL  33428
Applicant Contact DENNIS C ANDERSON
Correspondent
Inland Tube Corp.
4629 Biston St.
Boca Raton,  FL  33428
Correspondent Contact DENNIS C ANDERSON
Regulation Number892.1760
Classification Product Code
ITY  
Date Received08/19/1987
Decision Date 11/02/1987
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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