The following data is part of a premarket notification filed by Spenco Medical Corp. with the FDA for Spencio Skin Guard Kit.
| Device ID | K910927 |
| 510k Number | K910927 |
| Device Name: | SPENCIO SKIN GUARD KIT |
| Classification | Bandage, Liquid |
| 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 | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-05 |
| Decision Date | 1991-06-03 |