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FDA 510(k) Application Details - K990710
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K990710
Device Name
Surgeon'S Gloves
Applicant
BARRIERMED GLOVE CO.
2500 WEST LAKE MARY BLVD.
LAKE MARY, FL 32746 US
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Contact
CARLO PONCIPE
Other 510(k) Applications for this Contact
Regulation Number
878.4460
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Classification Product Code
KGO
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More FDA Info for this Product Code
Date Received
03/04/1999
Decision Date
05/20/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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