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FDA 510(k) Application Details - K180542
Device Classification Name
More FDA Info for this Device
510(K) Number
K180542
Device Name
NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe
Applicant
Boston Endo Surgical Tech,
Division of Lacey Manufacturing Co., LLC
1146 Barnum Ave
Bridgeport, CT 06610 US
Other 510(k) Applications for this Company
Contact
James Rogers
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PDQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/01/2018
Decision Date
08/22/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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