The following data is part of a premarket notification filed by Crosstex Intl. with the FDA for Crosstex Isolite Earloop Face Masks-blue, Pink, Crosstex Isofluid Earloop Face Masks-blue, Pink, White, Green. Crosstex.
| Device ID | K012602 |
| 510k Number | K012602 |
| Device Name: | CROSSTEX ISOLITE EARLOOP FACE MASKS-BLUE, PINK, CROSSTEX ISOFLUID EARLOOP FACE MASKS-BLUE, PINK, WHITE, GREEN. CROSSTEX |
| Classification | Mask, Surgical |
| Applicant | CROSSTEX INTL. 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk CROSSTEX INTL. 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11021 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-13 |
| Decision Date | 2002-01-22 |
| Summary: | summary |