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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 K945824
Device Name GALAXY MD SERIES THERAPYPOOLS
Applicant
Galaxy Aquatics, Inc.
1075 W. Sam Houston Pkwy. N.
Suite #210
Houston,  TX  77043
Applicant Contact KLAUS P KLOSTERMAN
Correspondent
Galaxy Aquatics, Inc.
1075 W. Sam Houston Pkwy. N.
Suite #210
Houston,  TX  77043
Correspondent Contact KLAUS P KLOSTERMAN
Regulation Number890.5380
Classification Product Code
BXB  
Date Received11/29/1994
Decision Date 04/05/1995
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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