The following data is part of a premarket notification filed by Crosstex Intl. with the FDA for Crosstex Non-woven Sponges.
| Device ID | K984187 |
| 510k Number | K984187 |
| Device Name: | CROSSTEX NON-WOVEN SPONGES |
| Classification | Gauze/sponge, Internal |
| Applicant | CROSSTEX INTL. 55 NORTHERN BLVD., SUITE 410 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk CROSSTEX INTL. 55 NORTHERN BLVD., SUITE 410 Great Neck, NY 11021 |
| Product Code | EFQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-23 |
| Decision Date | 1999-02-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50732224004247 | K984187 | 000 |
| 50732224004308 | K984187 | 000 |
| 50732224004292 | K984187 | 000 |
| 50732224004285 | K984187 | 000 |
| 50732224004278 | K984187 | 000 |
| 50732224004261 | K984187 | 000 |
| 50732224004254 | K984187 | 000 |