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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 K982696
Device Name INTERPLANT
Applicant
BURDETTE MEDICAL SYSTEMS, INC.
206 N. RANDOLPH ST.
SUITE 301
CHAMPAIGN,  IL  61820
Applicant Contact EVERETTE C BURDETTE
Correspondent
BURDETTE MEDICAL SYSTEMS, INC.
206 N. RANDOLPH ST.
SUITE 301
CHAMPAIGN,  IL  61820
Correspondent Contact EVERETTE C BURDETTE
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received08/03/1998
Decision Date 04/01/1999
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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