The following data is part of a premarket notification filed by Tyco Healthcare with the FDA for Kendall Ultec Pro Ag+ Hydrocolloid Dressing.
| Device ID | K033453 |
| 510k Number | K033453 |
| Device Name: | KENDALL ULTEC PRO AG+ HYDROCOLLOID DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | TYCO HEALTHCARE 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Contact | Gail Christie |
| Correspondent | Gail Christie TYCO HEALTHCARE 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2003-10-30 |
| Decision Date | 2004-04-29 |
| Summary: | summary |