The following data is part of a premarket notification filed by Cardinal Health 200, Llc with the FDA for Insta-gard Surgical And Procedure Face Mask.
| Device ID | K142990 |
| 510k Number | K142990 |
| Device Name: | Insta-Gard Surgical And Procedure Face Mask |
| Classification | Mask, Surgical |
| Applicant | Cardinal Health 200, LLC 1500 Waukegan Road Waukegan, IL 60085 |
| Contact | Lavenia Ford |
| Correspondent | Lavenia Ford Cardinal Health 200, LLC 1500 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 | 2014-10-16 |
| Decision Date | 2015-03-04 |
| Summary: | summary |