The following data is part of a premarket notification filed by Mascot, Inc. with the FDA for Mascot Lab Sponge.
| Device ID | K894984 |
| 510k Number | K894984 |
| Device Name: | MASCOT LAB SPONGE |
| Classification | Gauze/sponge, Internal, X-ray Detectable |
| 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 | GDY |
| CFR Regulation Number | 878.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-08 |
| Decision Date | 1989-09-05 |