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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 K832913
Device Name BACK MASSAGER B-400 ADJUSTABLE
Applicant
Pollenex Associated Mills, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Pollenex Associated Mills, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number890.5660
Classification Product Code
ISA  
Date Received08/29/1983
Decision Date 11/07/1983
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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