K012602 is an FDA 510(k) clearance for the CROSSTEX ISOLITE EARLOOP FACE MASKS-BLUE, PINK, CROSSTEX ISOFLUID EARLOOP FACE MASKS-BLUE, PINK, WHITE, GREEN. CROSSTEX. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Crosstex Intl. (Great Neck, US). The FDA issued a Cleared decision on January 22, 2002, 162 days after receiving the submission on August 13, 2001.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K012602 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 13, 2001 |
| Decision Date | January 22, 2002 |
| Days to Decision | 162 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FXX — Mask, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |