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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 K981424
Device Name NOMOS BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM
Applicant
Nomos Corp.
2591 Wexford Bayne Rd.
Suite 400
Sewickley,  PA  15143
Applicant Contact MARVIN L SUSSMAN
Correspondent
Nomos Corp.
2591 Wexford Bayne Rd.
Suite 400
Sewickley,  PA  15143
Correspondent Contact MARVIN L SUSSMAN
Regulation Number892.5050
Classification Product Code
IYE  
Date Received04/20/1998
Decision Date 07/17/1998
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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