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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Thermal Regulating
510(k) Number K003368
Device Name ACROTHERM
Applicant
Aquarius Medical Corp.
16047 N. 82nd St.
Suite B-1
Scottsdale,  AZ  85260
Applicant Contact CHRISTINA M FLEMING
Correspondent
Aquarius Medical Corp.
16047 N. 82nd St.
Suite B-1
Scottsdale,  AZ  85260
Correspondent Contact CHRISTINA M FLEMING
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received10/30/2000
Decision Date 01/19/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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