The following data is part of a premarket notification filed by Graphic Controls Corp. with the FDA for Life Trace(r) Bilirubin Mask.
| Device ID | K926118 |
| 510k Number | K926118 |
| Device Name: | LIFE TRACE(R) BILIRUBIN MASK |
| Classification | Pad, Neonatal Eye |
| Applicant | GRAPHIC CONTROLS CORP. 189 VAN RENSSELAER ST. P.O. BOX 1274 Buffalo, NY 14240 |
| Contact | John H Barrett |
| Correspondent | John H Barrett GRAPHIC CONTROLS CORP. 189 VAN RENSSELAER ST. P.O. BOX 1274 Buffalo, NY 14240 |
| Product Code | FOK |
| CFR Regulation Number | 880.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-03 |
| Decision Date | 1993-03-15 |