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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name System, Communication, Powered
510(k) Number K935981
Device Name MLT-2
Applicant
Med Labs, Inc.
28 Vereda Cordillera
Goleta,  CA  93117
Applicant Contact PHILIP D NORVELL
Correspondent
Med Labs, Inc.
28 Vereda Cordillera
Goleta,  CA  93117
Correspondent Contact PHILIP D NORVELL
Regulation Number890.3710
Classification Product Code
ILQ  
Date Received12/14/1993
Decision Date 02/17/1994
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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