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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, Transcutaneous, For Pain Relief
510(k) Number K910727
Device Name EXCEL MODEL 2110
Applicant
Excel Medical Systems, Inc.
2351 Damascus Ct.
San Jose,  CA  95125
Applicant Contact GLEN BOVARD
Correspondent
Excel Medical Systems, Inc.
2351 Damascus Ct.
San Jose,  CA  95125
Correspondent Contact GLEN BOVARD
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received02/20/1991
Decision Date 01/17/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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