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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 K993895
Device Name OPTIRAD
Applicant
PERMEDICS, INC.
3722 SAUSALITO AVE.
IRVINE,  CA  92606
Applicant Contact GREG HOLLAND
Correspondent
PERMEDICS, INC.
3722 SAUSALITO AVE.
IRVINE,  CA  92606
Correspondent Contact GREG HOLLAND
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received11/16/1999
Decision Date 06/02/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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