The following data is part of a premarket notification filed by Ormed Mfg., Inc. with the FDA for Triangle Sponge.
| Device ID | K880907 |
| 510k Number | K880907 |
| Device Name: | TRIANGLE SPONGE |
| Classification | Gauze/sponge, Internal |
| Applicant | ORMED MFG., INC. 175 GREAT ARROW AVE. Buffalo, NY 14207 |
| Contact | Ann M Johnson |
| Correspondent | Ann M Johnson ORMED MFG., INC. 175 GREAT ARROW AVE. Buffalo, NY 14207 |
| 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 | 1988-03-03 |
| Decision Date | 1988-03-17 |