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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Battery-Powered
510(k) Number K021033
Device Name STIMUPLEX-DIG-RC NERVE STIMULATOR
Applicant
B.Braun Medical, Inc.
901 Marcon Blvd.
Allentown,  PA  18109
Applicant Contact SHERI L MUSGNUNG
Correspondent
B.Braun Medical, Inc.
901 Marcon Blvd.
Allentown,  PA  18109
Correspondent Contact SHERI L MUSGNUNG
Regulation Number868.2775
Classification Product Code
BXN  
Date Received03/29/2002
Decision Date 03/21/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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