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510(k) K110528

INTEGRA LED SURGICAL HEADLIGHT SYSTEM by Integra LifeSciences Corporation — Product Code FSR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 2011
Date Received
February 24, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Headband, Surgical
Device Class
Class II
Regulation Number
886.4335
Review Panel
OP
Submission Type

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Other clearances for product code FSR

  • K031549 — SOLID STATE LAMP [LED] HEADLIGHT (August 11, 2003)
  • K031548 — LED HEADLIGHT (August 11, 2003)
  • K994362 — HEADLAMP HL2000. (May 11, 2000)