The following data is part of a premarket notification filed by Ndm Corp. with the FDA for Clearsite Sterile Wound Dressing, Ndm Wound Dressi.
| Device ID | K926202 |
| 510k Number | K926202 |
| Device Name: | CLEARSITE STERILE WOUND DRESSING, NDM WOUND DRESSI |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | NDM CORP. PO BOX 1408 Dayton, OH 45401 |
| Contact | Donald E Koopman |
| Correspondent | Donald E Koopman NDM CORP. PO BOX 1408 Dayton, OH 45401 |
| 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 | 1992-12-09 |
| Decision Date | 1993-05-12 |