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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Expander, Tissue, Orbital
510(k) Number K060151
Device Name ORBITAL TISSUE EXPANDER (OTE)
Applicant
Innovia, LLC
12415 SW 136 Ave.
Unit 3
Miami,  FL  33186
Applicant Contact STEWART B DAVIS
Correspondent
Innovia, LLC
12415 SW 136 Ave.
Unit 3
Miami,  FL  33186
Correspondent Contact STEWART B DAVIS
Regulation Number886.3320
Classification Product Code
NFM  
Date Received01/20/2006
Decision Date 08/08/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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