The following data is part of a premarket notification filed by Crosstex International with the FDA for Crosstex Isolite And Isofluid Earloop Face Masks And Isofluid Fogfree Face Masks With And Without Splash Visor.
| Device ID | K082258 |
| 510k Number | K082258 |
| Device Name: | CROSSTEX ISOLITE AND ISOFLUID EARLOOP FACE MASKS AND ISOFLUID FOGFREE FACE MASKS WITH AND WITHOUT SPLASH VISOR |
| Classification | Mask, Surgical |
| Applicant | CROSSTEX INTERNATIONAL 14605 28TH AVENUE NORTH Minneapolis, MN 55447 |
| Contact | Richard M Ormsbee |
| Correspondent | Richard M Ormsbee CROSSTEX INTERNATIONAL 14605 28TH AVENUE NORTH Minneapolis, MN 55447 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-08 |
| Decision Date | 2008-10-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889950133542 | K082258 | 000 |
| 10889950134082 | K082258 | 000 |
| 50732224120206 | K082258 | 000 |