The following data is part of a premarket notification filed by Stephenson Industries, Inc. with the FDA for Topical Hyperbaric Oxygen Chamber.
| Device ID | K861593 |
| 510k Number | K861593 |
| Device Name: | TOPICAL HYPERBARIC OXYGEN CHAMBER |
| Classification | Chamber, Oxygen, Topical, Extremity |
| Applicant | STEPHENSON INDUSTRIES, INC. P. O. BOX 1000 Farmingdale, NJ 07727 |
| Contact | R. A Lasley |
| Correspondent | R. A Lasley STEPHENSON INDUSTRIES, INC. P. O. BOX 1000 Farmingdale, NJ 07727 |
| Product Code | KPJ |
| CFR Regulation Number | 878.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-29 |
| Decision Date | 1986-05-12 |