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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Iontophoresis, Specific Uses
510(k) Number K992874
Device Name Q-SWEAT QUANTITATIVE SWEAT MEASUREMENT SYSTEM
Applicant
Wr Medical Electronics Co.
123 #2nd.St.
Stillwater,  MN  55082
Applicant Contact PATRICK J ANDERSON
Correspondent
Wr Medical Electronics Co.
123 #2nd.St.
Stillwater,  MN  55082
Correspondent Contact PATRICK J ANDERSON
Regulation Number890.5525
Classification Product Code
KTB  
Date Received08/26/1999
Decision Date 11/18/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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