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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Therapeutic, Electric
510(k) Number K925907
Device Name AQUASSAGER WM110/W210 & WM120 BODY BASICS MASSAGER
Applicant
Pollenex Corp.
165 N. Canal St.
Chicago,  IL  60606
Applicant Contact MICHAEL SKUPIEN
Correspondent
Pollenex Corp.
165 N. Canal St.
Chicago,  IL  60606
Correspondent Contact MICHAEL SKUPIEN
Regulation Number890.5660
Classification Product Code
ISA  
Date Received11/20/1992
Decision Date 03/30/1994
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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