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FDA 510(k) Application Details - K002131
Device Classification Name
Splint, Intranasal Septal
More FDA Info for this Device
510(K) Number
K002131
Device Name
Splint, Intranasal Septal
Applicant
WALTER LORENZ SURGICAL, INC.
1520 TRADEPORT DR.
JACKSONVILLE, FL 32218 US
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Contact
TREVOR BYRD
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Regulation Number
874.4780
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Classification Product Code
LYA
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More FDA Info for this Product Code
Date Received
07/14/2000
Decision Date
04/13/2001
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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