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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilant, Medical Devices
510(k) Number K984270
Device Name VAPO-SOLUTION FOR USE IN MDT HARVEY CHEMICLAVE STERILIZERS, MODELS 5000, 5500, AND 6000
Applicant
Roger L. Goodman, D.D.S., P.C.
200 Temple St.
Mason,  MI  48854 -1837
Applicant Contact ROGER L GOODMAN
Correspondent
Roger L. Goodman, D.D.S., P.C.
200 Temple St.
Mason,  MI  48854 -1837
Correspondent Contact ROGER L GOODMAN
Regulation Number880.6885
Classification Product Code
MED  
Date Received11/30/1998
Decision Date 05/20/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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