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FDA 510(k) Application Details - K964921
Device Classification Name
General Surgery Tray
More FDA Info for this Device
510(K) Number
K964921
Device Name
General Surgery Tray
Applicant
TRINITY LABORATORIES, INC.
201 KILEY DR.
SALISBURY, MD 21801 US
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Contact
PARTHA BASUMALLIK
Other 510(k) Applications for this Contact
Regulation Number
878.4370
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Classification Product Code
LRO
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More FDA Info for this Product Code
Date Received
12/09/1996
Decision Date
01/22/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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