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FDA 510(k) Application Details - K101567
Device Classification Name
Container, Sharps
More FDA Info for this Device
510(K) Number
K101567
Device Name
Container, Sharps
Applicant
CIXI LEINUO PLASTIC CO. LTD
NO. 56 LUOMING SOUTH ROAD
GUANHAIWEI TOWN , CIXI
NINGBO 315316 CN
Other 510(k) Applications for this Company
Contact
CHARLES MACK
Other 510(k) Applications for this Contact
Regulation Number
880.5570
More FDA Info for this Regulation Number
Classification Product Code
MMK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/04/2010
Decision Date
09/02/2010
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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