510(k) K110528
K110528 is an FDA 510(k) premarket notification submitted by Integra LifeSciences Corporation for the device "INTEGRA LED SURGICAL HEADLIGHT SYSTEM". The FDA issued a decision of Substantially Equivalent on May 11, 2011. The device falls under product code FSR (Light, Headband, Surgical), a Class II device regulated under 21 CFR 886.4335. Integra LifeSciences Corporation has at least 10 other 510(k) clearances on record.
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