The following data is part of a premarket notification filed by Integra Life Sciences Corporation with the FDA for Integra Led Surgical Headlight System.
| Device ID | K110528 |
| 510k Number | K110528 |
| Device Name: | INTEGRA LED SURGICAL HEADLIGHT SYSTEM |
| Classification | Light, Headband, Surgical |
| Applicant | INTEGRA LIFE SCIENCES CORPORATION 589 DAVIES DRIVE York, PA 17402 |
| Contact | Stephanie Sheesley |
| Correspondent | Stephanie Sheesley INTEGRA LIFE SCIENCES CORPORATION 589 DAVIES DRIVE York, PA 17402 |
| Product Code | FSR |
| CFR Regulation Number | 886.4335 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-24 |
| Decision Date | 2011-05-11 |
| Summary: | summary |