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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Galvanic Skin Response Measurement
510(k) Number K102166
Device Name ELECTRO INTERSTITIAL SCAN
Applicant
Ld Technology, LLC
11459 NW 34 St.
Miami,  FL  33178
Applicant Contact RICHARD CLEMENT
Correspondent
Ld Technology, LLC
11459 NW 34 St.
Miami,  FL  33178
Correspondent Contact RICHARD CLEMENT
Regulation Number882.1540
Classification Product Code
GZO  
Date Received08/02/2010
Decision Date 12/10/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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