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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Photic, Evoked Response
510(k) Number K043367
Device Name GLAID OCULAR ELECTROPHYSIOLOGY DEVICE
Applicant
Lace Electronica S.R.L.
2454 Mcmullen Booth Rd.
Suite 427
Clearwater,  FL  33759
Applicant Contact IAN P GORDON
Correspondent
Lace Electronica S.R.L.
2454 Mcmullen Booth Rd.
Suite 427
Clearwater,  FL  33759
Correspondent Contact IAN P GORDON
Regulation Number882.1890
Classification Product Code
GWE  
Date Received12/08/2004
Decision Date 11/17/2005
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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