FDA 510(k) Application Details - K110528

Device Classification Name	Light, Headband, Surgical   More FDA Info for this Device
510(K) Number	K110528
Device Name	Light, Headband, Surgical
Applicant	INTEGRA LIFE SCIENCES CORPORATION 589 DAVIES DRIVE YORK, PA 17402 US Other 510(k) Applications for this Company
Contact	STEPHANIE SHEESLEY Other 510(k) Applications for this Contact
Regulation Number	886.4335   More FDA Info for this Regulation Number
Classification Product Code	FSR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/24/2011
Decision Date	05/11/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review