The following data is part of a premarket notification filed by American Threshold Industries, Inc. with the FDA for Disposable O.r. Towel.
| Device ID | K912110 |
| 510k Number | K912110 |
| Device Name: | DISPOSABLE O.R. TOWEL |
| Classification | Drape, Surgical |
| Applicant | AMERICAN THRESHOLD INDUSTRIES, INC. 240 SARDIS RD. P.O. BOX 1209 Enka, NC 28728 |
| Contact | Robert T Bayer |
| Correspondent | Robert T Bayer AMERICAN THRESHOLD INDUSTRIES, INC. 240 SARDIS RD. P.O. BOX 1209 Enka, NC 28728 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-13 |
| Decision Date | 1991-07-25 |