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FDA 510(k) Application Details - K982885
Device Classification Name
Vinyl Patient Examination Glove
More FDA Info for this Device
510(K) Number
K982885
Device Name
Vinyl Patient Examination Glove
Applicant
SHANGHAI POSEIDON PLASTIC PRODUCTS CO., LTD.
30798 US HWY 19 N
PALM HARBOR, FL 34684 US
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Contact
DON MORRIS
Other 510(k) Applications for this Contact
Regulation Number
880.6250
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Classification Product Code
LYZ
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More FDA Info for this Product Code
Date Received
08/17/1998
Decision Date
12/04/1998
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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