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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Transcutaneous, For Arthritis
510(k) Number K030332
Device Name MODIFICATION TO BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000
Applicant
Bionicare Medical Technologies, Inc.
47 R Loveton Circle
Sparks,  MD  21152
Applicant Contact KENT HOFFMAN
Correspondent
Bionicare Medical Technologies, Inc.
47 R Loveton Circle
Sparks,  MD  21152
Correspondent Contact KENT HOFFMAN
Regulation Number882.5890
Classification Product Code
NYN  
Date Received01/31/2003
Decision Date 06/06/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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