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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Planning, Radiation Therapy Treatment
510(k) Number K993675
Device Name PEREGRINE RADIATION THERAPY DOSE CALCULATION SYSTEM
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 Number892.5050
Classification Product Code
MUJ  
Date Received11/01/1999
Decision Date 09/05/2000
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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