The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Sterile Gauze Sponges.
| Device ID | K930697 |
| 510k Number | K930697 |
| Device Name: | MEDLINE STERILE GAUZE SPONGES |
| Classification | Gauze/sponge, Internal, X-ray Detectable |
| Applicant | MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Contact | Donald Barham |
| Correspondent | Donald Barham MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Product Code | GDY |
| Subsequent Product Code | EFQ |
| Subsequent Product Code | FRO |
| Subsequent Product Code | NAB |
| CFR Regulation Number | 878.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-10 |
| Decision Date | 1993-06-24 |