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FDA 510(k) Application Details - K021033
Device Classification Name
Stimulator, Nerve, Battery-Powered
More FDA Info for this Device
510(K) Number
K021033
Device Name
Stimulator, Nerve, Battery-Powered
Applicant
B. BRAUN MEDICAL, INC.
901 MARCON BLVD.
ALLENTOWN, PA 18109-9341 US
Other 510(k) Applications for this Company
Contact
SHERI L MUSGNUNG
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
03/29/2002
Decision Date
03/21/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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