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FDA 510(k) Application Details - K091720
Device Classification Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
More FDA Info for this Device
510(K) Number
K091720
Device Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant
SKLAR CORP.
55 Northern Blvd
Suite 200
Great Neck, NY 11021 US
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Contact
NATALYA VALERIO
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Regulation Number
880.6850
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Classification Product Code
KCT
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More FDA Info for this Product Code
Date Received
06/11/2009
Decision Date
04/09/2010
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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