INTEGRA LED SURGICAL HEADLIGHT SYSTEM— 510(k) K110528
Substantially EquivalentIntegra LifeSciences Corporation
FDA 510(k) clearance K110528 for INTEGRA LED SURGICAL HEADLIGHT SYSTEM, Substantially Equivalent on 2011-05-11. Applicant: Integra LifeSciences Corporation. Device class: 2.
Clearance details
- Applicant
- Integra LifeSciences Corporation
- Product code
- Code FSR
- Device class
- Class 2
- Regulation
- 21 CFR 886.4335
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- York, PA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.