The following data is part of a premarket notification filed by Baldur Systems Corp. with the FDA for Operating Room Towels.
| Device ID | K981823 |
| 510k Number | K981823 |
| Device Name: | OPERATING ROOM TOWELS |
| Classification | Drape, Surgical |
| Applicant | BALDUR SYSTEMS CORP. 25 HERITAGE DR. Asheville, NC 28806 |
| Contact | Steve Woody |
| Correspondent | Steve Woody BALDUR SYSTEMS CORP. 25 HERITAGE DR. Asheville, NC 28806 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-22 |
| Decision Date | 1998-08-11 |