The following data is part of a premarket notification filed by O.r. Solutions, Inc. with the FDA for Ors-111.
| Device ID | K953654 |
| 510k Number | K953654 |
| Device Name: | ORS-111 |
| Classification | Drape, Surgical |
| Applicant | O.R. SOLUTIONS, INC. 14014 SULLYFIELD CIRCLE SUITE A Chantilly, VA 22021 |
| Contact | Mark Licata |
| Correspondent | Mark Licata O.R. SOLUTIONS, INC. 14014 SULLYFIELD CIRCLE SUITE A Chantilly, VA 22021 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-02 |
| Decision Date | 1995-09-22 |