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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Body Composition
510(k) Number K081587
Device Name KRELL WEIGHT & BODY FAT MONITORING SCALE, MODEL BFA-8530
Applicant
Krell Precision (Yang Zhou) Co., Ltd.
340 Shady Grove Rd.
Flintville,  TN  37335
Applicant Contact CHARLIE MACK
Correspondent
Krell Precision (Yang Zhou) Co., Ltd.
340 Shady Grove Rd.
Flintville,  TN  37335
Correspondent Contact CHARLIE MACK
Regulation Number870.2770
Classification Product Code
MNW  
Date Received06/05/2008
Decision Date 10/24/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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