The following data is part of a premarket notification filed by Kendall Healthcare Products Co. Div.of Tyco Health with the FDA for Curagel Hydrogel Wound Dressing.
| Device ID | K950412 |
| 510k Number | K950412 |
| Device Name: | CURAGEL HYDROGEL WOUND DRESSING |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Contact | David A Olson |
| Correspondent | David A Olson KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Product Code | MGQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-31 |
| Decision Date | 1995-03-24 |