The following data is part of a premarket notification filed by Clinical Resources, Inc. with the FDA for Fluff Gauze Sponge.
| Device ID | K945021 |
| 510k Number | K945021 |
| Device Name: | FLUFF GAUZE SPONGE |
| Classification | Gauze/sponge, Internal |
| 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 | EFQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-12 |
| Decision Date | 1994-12-23 |