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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name transducer, tremor
510(k) Number K011429
Device Name MODEL 100 ACTIVITY MONITOR
Applicant
TELECOM MEDICAL, INC.
10900 LUCKY OAK COURT
CUPERTINO,  CA  95014
Applicant Contact THOMAS C WEHMAN
Correspondent
TELECOM MEDICAL, INC.
10900 LUCKY OAK COURT
CUPERTINO,  CA  95014
Correspondent Contact THOMAS C WEHMAN
Regulation Number882.1950
Classification Product Code
GYD  
Subsequent Product Codes
KQX   LBB  
Date Received05/09/2001
Decision Date 07/13/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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