The following data is part of a premarket notification filed by Topox Therapeuutic Rentals, Inc. with the FDA for Topical Sacral Hyperbaric Oxygen Chamber.
| Device ID | K920948 |
| 510k Number | K920948 |
| Device Name: | TOPICAL SACRAL HYPERBARIC OXYGEN CHAMBER |
| Classification | Chamber, Oxygen, Topical, Extremity |
| Applicant | TOPOX THERAPEUUTIC RENTALS, INC. 45 WEST ST. SUITE 2 North Attleboro, MA 02703 |
| Contact | Lynne Aronson |
| Correspondent | Lynne Aronson TOPOX THERAPEUUTIC RENTALS, INC. 45 WEST ST. SUITE 2 North Attleboro, MA 02703 |
| Product Code | KPJ |
| CFR Regulation Number | 878.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-02 |
| Decision Date | 1992-08-11 |