The following data is part of a premarket notification filed by Mascot, Inc. with the FDA for Mascot O.r. Towel.
| Device ID | K894436 |
| 510k Number | K894436 |
| Device Name: | MASCOT O.R. TOWEL |
| Classification | Drape, Surgical |
| Applicant | MASCOT, INC. 16635 VALLEY VIEW Cerritos, CA 90701 |
| Contact | Ben Chang |
| Correspondent | Ben Chang MASCOT, INC. 16635 VALLEY VIEW Cerritos, CA 90701 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-17 |
| Decision Date | 1989-08-11 |