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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Bed, Flotation Therapy, Powered
510(k) Number K894723
Device Name SYSTEM 2500 MEDICAL WATERBED
Applicant
DERMANETICS CORP.
741 W. 17TH ST.
LONG BEACH,  CA  90813
Applicant Contact SCOTT POSTLE
Correspondent
DERMANETICS CORP.
741 W. 17TH ST.
LONG BEACH,  CA  90813
Correspondent Contact SCOTT POSTLE
Regulation Number890.5170
Classification Product Code
IOQ  
Date Received07/25/1989
Decision Date 08/17/1989
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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