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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 K914943
Device Name AQUA MED
Applicant
Aqua Massage Intl., Inc.
P.O. Box 550
East Lyme,  CT  06333
Applicant Contact MARK T DALTON
Correspondent
Aqua Massage Intl., Inc.
P.O. Box 550
East Lyme,  CT  06333
Correspondent Contact MARK T DALTON
Regulation Number890.5660
Classification Product Code
ISA  
Date Received11/04/1991
Decision Date 04/02/1992
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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