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FDA 510(k) Application Details - K061172
Device Classification Name
Stimulator, Nerve, Battery-Powered
More FDA Info for this Device
510(K) Number
K061172
Device Name
Stimulator, Nerve, Battery-Powered
Applicant
PAJUNK GMBH MEDIZINTECHNOLOGIE
106 EAST 5TH AVENUE
MOUNT DORA, FL 32757 US
Other 510(k) Applications for this Company
Contact
LYNETTE L HOWARD
Other 510(k) Applications for this Contact
Regulation Number
868.2775
More FDA Info for this Regulation Number
Classification Product Code
BXN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/27/2006
Decision Date
10/17/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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