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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 K915729
Device Name AUQASOOTHE/AQUA MED
Applicant
Aquasoothe
2808 Concord Lake Rd.
Kannapolis,  NC  28083
Applicant Contact DAVE B MARLIN
Correspondent
Aquasoothe
2808 Concord Lake Rd.
Kannapolis,  NC  28083
Correspondent Contact DAVE B MARLIN
Regulation Number890.5660
Classification Product Code
ISA  
Date Received12/20/1991
Decision Date 04/29/1992
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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