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FDA 510(k) Application Details - K051242
Device Classification Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
More FDA Info for this Device
510(K) Number
K051242
Device Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant
WINNER MEDICAL (USA), INC.
1900 PROFORMA AVE. #H
ONTARIO, CA 91761 US
Other 510(k) Applications for this Company
Contact
MING XIE
Other 510(k) Applications for this Contact
Regulation Number
880.6850
More FDA Info for this Regulation Number
Classification Product Code
KCT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/13/2005
Decision Date
12/13/2005
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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