The following data is part of a premarket notification filed by Gillen Industries with the FDA for Full Body Restraint System.
| Device ID | K972046 |
| 510k Number | K972046 |
| Device Name: | FULL BODY RESTRAINT SYSTEM |
| Classification | Restraint, Protective |
| Applicant | GILLEN INDUSTRIES ONE RICHMOND SQ. STE. 180 Providence, RI 02906 |
| Contact | John Gillen |
| Correspondent | John Gillen GILLEN INDUSTRIES ONE RICHMOND SQ. STE. 180 Providence, RI 02906 |
| Product Code | FMQ |
| CFR Regulation Number | 880.6760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-02 |
| Decision Date | 1997-08-15 |