The following data is part of a premarket notification filed by Clinical Resources, Inc. with the FDA for Gauze Sponges.
| Device ID | K944879 |
| 510k Number | K944879 |
| Device Name: | GAUZE SPONGES |
| Classification | Gauze/sponge, Internal, X-ray Detectable |
| Applicant | CLINICAL RESOURCES, INC. 825A TOLLGATE RD. Elgin, IL 60123 |
| Contact | David Insco |
| Correspondent | David Insco CLINICAL RESOURCES, INC. 825A TOLLGATE RD. Elgin, IL 60123 |
| Product Code | GDY |
| CFR Regulation Number | 878.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-03 |
| Decision Date | 1994-12-23 |