FDA 510(k) Application Details - K984270

Device Classification Name Sterilant, Medical Devices

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510(K) Number K984270
Device Name Sterilant, Medical Devices
Applicant ROGER L. GOODMAN, D.D.S., P.C.
200 TEMPLE ST.
MASON, MI 48854-1837 US
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Contact ROGER L GOODMAN
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Regulation Number 880.6885

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Classification Product Code MED
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Date Received 11/30/1998
Decision Date 05/20/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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