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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electronic Depth Gauge
510(k) Number K091992
Device Name EIDOSMED, MODEL EDG4.0
Applicant
Eidosmed, LLC
333 Milford Rd.
Deerfield,  IL  60015
Applicant Contact DANIEL KAMM
Correspondent
Eidosmed, LLC
333 Milford Rd.
Deerfield,  IL  60015
Correspondent Contact DANIEL KAMM
Regulation Number888.3030
Classification Product Code
OOL  
Date Received07/02/2009
Decision Date 12/09/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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