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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Exerciser, Powered
510(k) Number K945733
Device Name AQUAHAB, MODEL 120-72-101
Applicant
Aquarius Electronics, Inc.
6501 Linglestown Rd.
Harrisburg,  PA  17112
Applicant Contact RAYMON O WALMER, JR
Correspondent
Aquarius Electronics, Inc.
6501 Linglestown Rd.
Harrisburg,  PA  17112
Correspondent Contact RAYMON O WALMER, JR
Regulation Number890.5380
Classification Product Code
BXB  
Date Received11/23/1994
Decision Date 09/15/1995
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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