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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Couch, Radiation Therapy, Powered
510(k) Number K013036
Device Name NOMOS MOTORIZED CRANE II
Applicant
Nomos Corp.
2591 Wexford Bayne Rd.
Suite 400
Sewickley,  PA  15143
Applicant Contact FRANCIS X DOBSCHA
Correspondent
Nomos Corp.
2591 Wexford Bayne Rd.
Suite 400
Sewickley,  PA  15143
Correspondent Contact FRANCIS X DOBSCHA
Regulation Number892.5770
Classification Product Code
JAI  
Date Received09/10/2001
Decision Date 12/07/2001
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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