FDA 510(k) Application Details - K953068

Device Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

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510(K) Number K953068
Device Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant OXBORO MEDICAL INTL., INC.
13828 LINCOLN ST. N.E.
HAM LAKE, MN 55304 US
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Contact HARLEY HAADE
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Regulation Number 880.6850

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Classification Product Code KCT
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Date Received 06/30/1995
Decision Date 01/23/1996
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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