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FDA 510(k) Application Details - K955704
Device Classification Name
Bur, Ear, Nose And Throat
More FDA Info for this Device
510(K) Number
K955704
Device Name
Bur, Ear, Nose And Throat
Applicant
TREBAY MEDICAL CORP.
4911 CREEKSIDE DR.
CLEARWATER, FL 34620 US
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Contact
DAN H TREACE
Other 510(k) Applications for this Contact
Regulation Number
874.4140
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Classification Product Code
EQJ
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More FDA Info for this Product Code
Date Received
12/15/1995
Decision Date
01/30/1996
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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