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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 -5031
Applicant Contact CHARLIE MACK
Correspondent
KRELL PRECISION (YANG ZHOU) CO., LTD.
340 SHADY GROVE RD.
FLINTVILLE,  TN  37335 -5031
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
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