The following data is part of a premarket notification filed by Cardinal Health 200, Llc with the FDA for Secure-gard Surgical And Procedure Face Mask.
| Device ID | K140155 |
| 510k Number | K140155 |
| Device Name: | SECURE-GARD SURGICAL AND PROCEDURE FACE MASK |
| Classification | Mask, Surgical |
| Applicant | CARDINAL HEALTH 200, LLC 1430 WAUKEGAN ROAD Waukegan, IL 60085 |
| Contact | Lavenia Ford |
| Correspondent | Lavenia Ford CARDINAL HEALTH 200, LLC 1430 WAUKEGAN ROAD Waukegan, IL 60085 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-22 |
| Decision Date | 2014-06-20 |
| Summary: | summary |