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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 K853973
Device Name WESCOR MODEL 3700 WEBSTER SWEAT INDUCER
Applicant
Wescor, Inc.
459 S. Main
Logan,  UT  84321
Applicant Contact WAYNE K BARLOW
Correspondent
Wescor, Inc.
459 S. Main
Logan,  UT  84321
Correspondent Contact WAYNE K BARLOW
Regulation Number890.5525
Classification Product Code
KTB  
Date Received09/26/1985
Decision Date 10/16/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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