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FDA 510(k) Application Details - K964545
Device Classification Name
Vinyl Patient Examination Glove
More FDA Info for this Device
510(K) Number
K964545
Device Name
Vinyl Patient Examination Glove
Applicant
SHANGHAI POSEIDON PLASTIC PRODUCTS CO., LTD.
1202 SOUTH ROUTE 31
MC HENRY, IL 60050 US
Other 510(k) Applications for this Company
Contact
ANTHONY L GIACCIO
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LYZ
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More FDA Info for this Product Code
Date Received
11/13/1996
Decision Date
12/30/1996
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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