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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 K042861
Device Name ODYSSEY
Applicant
PERMEDICS, INC.
1475 SOUTH VICTORIA CT.
SAN BERNARDINO,  CA  92408
Applicant Contact JESSICA CONNOR
Correspondent
PERMEDICS, INC.
1475 SOUTH VICTORIA CT.
SAN BERNARDINO,  CA  92408
Correspondent Contact JESSICA CONNOR
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received10/15/2004
Decision Date 01/12/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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