The following data is part of a premarket notification filed by Stephenson Industries, Inc. with the FDA for Hyper Pulse Intermittent Topical Oxygen Chamber C-100, Cb-100.
| Device ID | K963777 |
| 510k Number | K963777 |
| Device Name: | HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-100 |
| Classification | Chamber, Oxygen, Topical, Extremity |
| Applicant | STEPHENSON INDUSTRIES, INC. 1648 BEAVER DAM RD. Point Pleasant, NJ 08742 |
| Contact | R A Lashly |
| Correspondent | R A Lashly STEPHENSON INDUSTRIES, INC. 1648 BEAVER DAM RD. Point Pleasant, NJ 08742 |
| Product Code | KPJ |
| CFR Regulation Number | 878.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-20 |
| Decision Date | 1997-07-28 |