FDA 510(k) Application Details - K021064

Device Classification Name Sterilizer, Steam

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510(K) Number K021064
Device Name Sterilizer, Steam
Applicant SCICAN
1440 DON MILLS RD.
TORONTO, ONTARIO M3B 3P9 CA
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Contact BRENDA MURPHY
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Regulation Number 880.6880

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Classification Product Code FLE
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Date Received 04/02/2002
Decision Date 08/08/2002
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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