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FDA 510(k) Application Details - K190782
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K190782
Device Name
Surgeon'S Gloves
Applicant
LDI Corporation
3560 Lafayette Road, Building 2
Portsmouth, NH 03801 US
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Contact
Lou LaMarca
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
03/27/2019
Decision Date
06/27/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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