The following data is part of a premarket notification filed by Crosstex International, Inc. with the FDA for Crosstex Isofluid Plus Surgical Earloop Mask-blue, Crosstex Isofluid Plus Fogfree Surgical Earloop Face Mask-blue, Cross.
| Device ID | K111343 |
| 510k Number | K111343 |
| Device Name: | CROSSTEX ISOFLUID PLUS SURGICAL EARLOOP MASK-BLUE, CROSSTEX ISOFLUID PLUS FOGFREE SURGICAL EARLOOP FACE MASK-BLUE, CROSS |
| Classification | Mask, Surgical |
| Applicant | CROSSTEX INTERNATIONAL, INC. 14605 28TH AVENUE NORTH Minneapolis, MN 55447 |
| Contact | Richard M Ormsbee |
| Correspondent | Richard M Ormsbee CROSSTEX INTERNATIONAL, INC. 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 | 2011-05-13 |
| Decision Date | 2011-10-06 |
| Summary: | summary |