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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
510(k) Number K022404
Device Name ACTIBAND
Applicant
Paw, LLC
5540 Hidden Waters Ln.
Frederick,  MD  21703
Applicant Contact ANDREW J WHELAN
Correspondent
Paw, LLC
5540 Hidden Waters Ln.
Frederick,  MD  21703
Correspondent Contact ANDREW J WHELAN
Regulation Number890.5290
Classification Product Code
ILX  
Date Received07/23/2002
Decision Date 08/08/2002
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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