The following data is part of a premarket notification filed by The Kendall Company with the FDA for Excilon Amd Antimicrobial Sponge Model #7088.
| Device ID | K011941 |
| 510k Number | K011941 |
| Device Name: | EXCILON AMD ANTIMICROBIAL SPONGE MODEL #7088 |
| Classification | Gauze/sponge, Internal |
| Applicant | THE KENDALL COMPANY 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Contact | Michael Spears |
| Correspondent | Michael Spears THE KENDALL COMPANY 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| 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 | 2001-06-21 |
| Decision Date | 2001-08-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884521152185 | K011941 | 000 |
| 20884521020181 | K011941 | 000 |
| 00884521026868 | K011941 | 000 |
| 00884521026882 | K011941 | 000 |
| 00884521026929 | K011941 | 000 |
| 00884521026950 | K011941 | 000 |
| 00884521026981 | K011941 | 000 |
| 00884521027001 | K011941 | 000 |
| 00884521152741 | K011941 | 000 |
| 00884521170790 | K011941 | 000 |
| 00884521153069 | K011941 | 000 |
| 20884521154084 | K011941 | 000 |