The following data is part of a premarket notification filed by Spenco Medical Corp. with the FDA for 2nd Skin Moist Burn Pads With Aloe.
| Device ID | K911550 |
| 510k Number | K911550 |
| Device Name: | 2ND SKIN MOIST BURN PADS WITH ALOE |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | SPENCO MEDICAL CORP. P.O. BOX 2501 Waco, TX 76702 |
| Contact | Smith |
| Correspondent | Smith SPENCO MEDICAL CORP. P.O. BOX 2501 Waco, TX 76702 |
| 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 | 1991-04-08 |
| Decision Date | 1991-09-06 |