The following data is part of a premarket notification filed by Baldur Systems Corp. with the FDA for Baldur Non-sterile Cotton Sponges.
| Device ID | K974347 |
| 510k Number | K974347 |
| Device Name: | BALDUR NON-STERILE COTTON SPONGES |
| Classification | Gauze/sponge, Internal |
| Applicant | BALDUR SYSTEMS CORP. 3423 INVESTMENT BLVD., #12 Hayward, CA 94545 |
| Contact | David Hu, Ph.d. |
| Correspondent | David Hu, Ph.d. BALDUR SYSTEMS CORP. 3423 INVESTMENT BLVD., #12 Hayward, CA 94545 |
| 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 | 1997-11-19 |
| Decision Date | 1998-02-10 |
| Summary: | summary |