The following data is part of a premarket notification filed by Damor America, Inc. with the FDA for Damor Cream Saturated Dressing.
| Device ID | K934267 |
| 510k Number | K934267 |
| Device Name: | DAMOR CREAM SATURATED DRESSING |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | DAMOR AMERICA, INC. COLUMBIA SQUARE 555 THIRTEENTH STREET NW Washington, DC 20004 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein DAMOR AMERICA, INC. COLUMBIA SQUARE 555 THIRTEENTH STREET NW Washington, DC 20004 |
| 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 | 1993-08-31 |
| Decision Date | 1993-12-07 |