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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical, Antimicrobial
510(k) Number K042977
Device Name LASIK EYE DRAPE
Applicant
Odyssey Medical, Inc.
5828 Shelby Oaks Dr.
Memphis,  TN  38134
Applicant Contact IVAN HARLAN
Correspondent
Odyssey Medical, Inc.
5828 Shelby Oaks Dr.
Memphis,  TN  38134
Correspondent Contact IVAN HARLAN
Regulation Number878.4370
Classification Product Code
KKX  
Date Received10/28/2004
Decision Date 05/10/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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