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FDA 510(k) Application Details - K980137
Device Classification Name
General Surgery Tray
More FDA Info for this Device
510(K) Number
K980137
Device Name
General Surgery Tray
Applicant
WORLDWIDE MEDICAL TECHNOLOGIES, LLC
125 MAIN ST., NORTH
WOODBURY, CT 06798-0505 US
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Contact
GARY LAMOUREUX
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
01/15/1998
Decision Date
01/30/1998
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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