The following data is part of a premarket notification filed by Oxyfast Corporation with the FDA for Oxybox System.
| Device ID | K023456 |
| 510k Number | K023456 |
| Device Name: | OXYBOX SYSTEM |
| Classification | Chamber, Oxygen, Topical, Extremity |
| Applicant | OXYFAST CORPORATION 11000 CEDAR AVE # 449 Cleveland, OH 44106 |
| Contact | Melvyn Burke |
| Correspondent | Melvyn Burke OXYFAST CORPORATION 11000 CEDAR AVE # 449 Cleveland, OH 44106 |
| Product Code | KPJ |
| CFR Regulation Number | 878.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-15 |
| Decision Date | 2003-02-24 |
| Summary: | summary |