The following data is part of a premarket notification filed by Spenco Medical Corp. with the FDA for 2nd Skin Sterile Adhesive Strip.
| Device ID | K922228 |
| 510k Number | K922228 |
| Device Name: | 2ND SKIN STERILE ADHESIVE STRIP |
| Classification | Tape And Bandage, Adhesive |
| Applicant | SPENCO MEDICAL CORP. P.O. BOX 2501 Waco, TX 76702 |
| Contact | Stan A Chambers |
| Correspondent | Stan A Chambers SPENCO MEDICAL CORP. P.O. BOX 2501 Waco, TX 76702 |
| Product Code | KGX |
| CFR Regulation Number | 880.5240 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-12 |
| Decision Date | 1992-12-11 |