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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name light, headband, surgical
510(k) Number K110528
Device Name INTEGRA LED SURGICAL HEADLIGHT SYSTEM
Applicant
INTEGRA LIFE SCIENCES CORPORATION
589 DAVIES DRIVE
YORK,  PA  17402
Applicant Contact STEPHANIE SHEESLEY
Correspondent
INTEGRA LIFE SCIENCES CORPORATION
589 DAVIES DRIVE
YORK,  PA  17402
Correspondent Contact STEPHANIE SHEESLEY
Regulation Number886.4335
Classification Product Code
FSR  
Date Received02/24/2011
Decision Date 05/11/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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