The following data is part of a premarket notification filed by Spenco Medical Corp. with the FDA for 2nd Skin Non-stick Moist Burn Pads.
| Device ID | K894898 |
| 510k Number | K894898 |
| Device Name: | 2ND SKIN NON-STICK MOIST BURN PADS |
| Classification | Dressing, Wound, Drug |
| Applicant | SPENCO MEDICAL CORP. P.O. BOX 2501 Waco, TX 76702 |
| Contact | James E Mcgowan |
| Correspondent | James E Mcgowan SPENCO MEDICAL CORP. P.O. BOX 2501 Waco, TX 76702 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-01 |
| Decision Date | 1989-08-23 |