The following data is part of a premarket notification filed by Pilgrim Medical Services with the FDA for Burns Casualty Sheet Burn Roll.
| Device ID | K900442 |
| 510k Number | K900442 |
| Device Name: | BURNS CASUALTY SHEET BURN ROLL |
| Classification | Sheet, Burn |
| Applicant | PILGRIM MEDICAL SERVICES THE OLD COACH HOUSE CHAPEL RD, ROTHERWAS, HEREFORD England Hr2 6sx, GB |
| Contact | Brown |
| Correspondent | Brown PILGRIM MEDICAL SERVICES THE OLD COACH HOUSE CHAPEL RD, ROTHERWAS, HEREFORD England Hr2 6sx, GB |
| Product Code | FPY |
| CFR Regulation Number | 880.5180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-30 |
| Decision Date | 1990-07-03 |