The following data is part of a premarket notification filed by Warne Surgical Products, Ltd. with the FDA for Paediatric Face Mask 1-3 W/wo Ring.
| Device ID | K834454 |
| 510k Number | K834454 |
| Device Name: | PAEDIATRIC FACE MASK 1-3 W/WO RING |
| Classification | Mask, Gas, Anesthetic |
| Applicant | WARNE SURGICAL PRODUCTS, LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BSJ |
| CFR Regulation Number | 868.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-19 |
| Decision Date | 1984-01-18 |