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510(k) K110528

Device
INTEGRA LED SURGICAL HEADLIGHT SYSTEM
Applicant
INTEGRA LIFE SCIENCES CORPORATION
510(k) number
K110528
Product code
FSR  
Decision
Substantially Equivalent (SESE)
Decision date
2011-05-11
Date received
2011-02-24
Regulation
886.4335
Classification name
Light, Headband, Surgical
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
STEPHANIE SHEESLEY
Address
589 Davies Dr. York PA US 17402 17402

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FSR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K031548LED HEADLIGHTWelch Allyn, Inc.2003-08-11
K031549SOLID STATE LAMP [LED] HEADLIGHTWelch Allyn, Inc.2003-08-11
K994362HEADLAMP HL2000.Angiolaz, Inc.2000-05-11

Legacy Summary#

summary

FDA Review#

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