FDA 510(k) Application Details - K962755

Device Classification Name Sterilizer, Steam

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510(K) Number K962755
Device Name Sterilizer, Steam
Applicant STRYKER CORP.
MEDICAL DIV.
6300 SPRINKLE RD.
KALAMAZOO, MI 49001-6197 US
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Contact CHAD COBERLY
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Regulation Number 880.6880

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Classification Product Code FLE
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Date Received 07/16/1996
Decision Date 03/04/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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