The following data is part of a premarket notification filed by Dukal Corp. with the FDA for Dukal Transparent Wound Dressing.
| Device ID | K955476 |
| 510k Number | K955476 |
| Device Name: | DUKAL TRANSPARENT WOUND DRESSING |
| Classification | Dressing, Wound And Burn, Occlusive |
| Applicant | DUKAL CORP. 1247 FLORIDA AVE. Palm Harbor, FL 34683 |
| Contact | Pat Lamb |
| Correspondent | Pat Lamb DUKAL CORP. 1247 FLORIDA AVE. Palm Harbor, FL 34683 |
| Product Code | MGP |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-30 |
| Decision Date | 1996-01-18 |