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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Block, Beam-Shaping, Radiation Therapy
510(k) Number K972016
Device Name AUTIMO 2.5-D AND AUTIMO 3-D
Applicant
C.L. Mcintosh & Assoc., Inc.
12300 Twinbrook Pkwy., Suite 625
Rockville,  MD  20852
Applicant Contact T. WHIT ATHEY
Correspondent
C.L. Mcintosh & Assoc., Inc.
12300 Twinbrook Pkwy., Suite 625
Rockville,  MD  20852
Correspondent Contact T. WHIT ATHEY
Regulation Number892.5710
Classification Product Code
IXI  
Date Received05/30/1997
Decision Date 12/04/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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