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 |