The following data is part of a premarket notification filed by Ormed Mfg., Inc. with the FDA for Color-eze Pre-washed Lap Sponges.
| Device ID | K831913 |
| 510k Number | K831913 |
| Device Name: | COLOR-EZE PRE-WASHED LAP SPONGES |
| Classification | Gauze/sponge, Internal, X-ray Detectable |
| Applicant | ORMED MFG., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GDY |
| CFR Regulation Number | 878.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-14 |
| Decision Date | 1983-09-26 |