The following data is part of a premarket notification filed by International Medsurg Connection with the FDA for Imc Surgical Face Mask.
| Device ID | K100846 |
| 510k Number | K100846 |
| Device Name: | IMC SURGICAL FACE MASK |
| Classification | Mask, Surgical |
| Applicant | INTERNATIONAL MEDSURG CONNECTION 935 N PLUM GROVE RD, STE F Schaumburg, IL 60173 |
| Contact | Peter Kim |
| Correspondent | Peter Kim INTERNATIONAL MEDSURG CONNECTION 935 N PLUM GROVE RD, STE F Schaumburg, IL 60173 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-25 |
| Decision Date | 2010-08-16 |
| Summary: | summary |