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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K870525
Device Name PHILIPS MODEL SL75-10 LINEAR ACCELERATOR
Applicant
Industrial Accelerator Co.
High Energy X-Ray Specialists
70 Acorn Hill Rd.
Woodbridge,  CT  06525
Applicant Contact PAUL H LEEK
Correspondent
Industrial Accelerator Co.
High Energy X-Ray Specialists
70 Acorn Hill Rd.
Woodbridge,  CT  06525
Correspondent Contact PAUL H LEEK
Regulation Number892.5050
Classification Product Code
IYE  
Date Received02/06/1987
Decision Date 04/01/1987
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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