The following data is part of a premarket notification filed by Crosstex International, Inc. with the FDA for Crosstex Surgical Earloop Mask- White, Crosstex Surgical Earloop No Fog Mask-white, No Fog Mask With Splash Visor-white.
| Device ID | K103303 |
| 510k Number | K103303 |
| Device Name: | CROSSTEX SURGICAL EARLOOP MASK- WHITE, CROSSTEX SURGICAL EARLOOP NO FOG MASK-WHITE, NO FOG MASK WITH SPLASH VISOR-WHITE |
| 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 | 2010-11-09 |
| Decision Date | 2010-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889950140243 | K103303 | 000 |
| 30304040168968 | K103303 | 000 |
| 30304040168975 | K103303 | 000 |
| 30304040168982 | K103303 | 000 |
| 20850455007963 | K103303 | 000 |
| 50732224005411 | K103303 | 000 |
| 50732224005442 | K103303 | 000 |
| 30732224005455 | K103303 | 000 |
| 10850455007973 | K103303 | 000 |
| 20850455007987 | K103303 | 000 |
| 00304040168950 | K103303 | 000 |
| 00304040168967 | K103303 | 000 |
| 00304040168974 | K103303 | 000 |
| 00304040168981 | K103303 | 000 |
| 30304040168951 | K103303 | 000 |