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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Collimator, Automatic, Radiographic
510(k) Number K861942
Device Name COLLIMATOR MODEL A280BLE & MODEL A280-BLM
Applicant
D&R X-Ray Products, Inc.
2428 Hanover Ave.
Richmond,  VA  23220
Applicant Contact DAVID P ARMSTRONG
Correspondent
D&R X-Ray Products, Inc.
2428 Hanover Ave.
Richmond,  VA  23220
Correspondent Contact DAVID P ARMSTRONG
Regulation Number892.1610
Classification Product Code
IZW  
Date Received05/20/1986
Decision Date 07/25/1986
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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