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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 K003231
Device Name HMS NEUROMUSCULAR STIMULATOR, MODEL HMS 3
Applicant
HOME MEDICAL SERVICES
9393 ACTIVITY RD., SUITE F
SAN DIEGO,  CA  92126
Applicant Contact C.A. TEKLINSKI
Correspondent
HOME MEDICAL SERVICES
9393 ACTIVITY RD., SUITE F
SAN DIEGO,  CA  92126
Correspondent Contact C.A. TEKLINSKI
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received10/17/2000
Decision Date 01/12/2001
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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