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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dynamometer, ac-powered
510(k) Number K052309
FOIA Releasable 510(k) K052309
Device Name DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006
Applicant
SAEHAN CORP.
340 SHADY GROVE ROAD
FLINTVILLE,  TN  37335
Applicant Contact CHARLIE MACK
Correspondent
SAEHAN CORP.
340 SHADY GROVE ROAD
FLINTVILLE,  TN  37335
Correspondent Contact CHARLIE MACK
Regulation Number888.1240
Classification Product Code
LBB  
Date Received08/24/2005
Decision Date 09/27/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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