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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K021472
Device Name HMS-DHR-3 NEUROMUSCULAR STIMULATOR
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 Number890.5850
Classification Product Code
IPF  
Date Received05/08/2002
Decision Date 08/06/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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