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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Muscle Monitoring
510(k) Number K030869
Device Name BITESTRIP
Applicant
S.L.P. , Ltd.
18 Hazfira St.
Tel-Aviv,  IL 67779
Applicant Contact TAMAR SHOCHAT
Correspondent
S.L.P. , Ltd.
18 Hazfira St.
Tel-Aviv,  IL 67779
Correspondent Contact TAMAR SHOCHAT
Regulation Number890.1375
Classification Product Code
KZM  
Date Received03/19/2003
Decision Date 05/14/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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