The following data is part of a premarket notification filed by O.r. Specialties, Inc. with the FDA for Dressing Change Trays & Sterile Sponges.
| Device ID | K811951 |
| 510k Number | K811951 |
| Device Name: | DRESSING CHANGE TRAYS & STERILE SPONGES |
| Classification | Gauze/sponge, Internal |
| Applicant | O.R. SPECIALTIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EFQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-07 |
| Decision Date | 1981-10-16 |