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FDA 510(k) Application Details - K982870
Device Classification Name
Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
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510(K) Number
K982870
Device Name
Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Applicant
XOMED, INC.
6743 SOUTHPOINT DR. NORTH
JACKSONVILLE, FL 32216-0980 US
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Contact
ROY BERENS
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Regulation Number
874.3620
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Classification Product Code
KHJ
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More FDA Info for this Product Code
Date Received
08/14/1998
Decision Date
11/03/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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