The following data is part of a premarket notification filed by Spenco Medical Corp. with the FDA for Spenco Silicone Gel Sheet.
| Device ID | K981902 |
| 510k Number | K981902 |
| Device Name: | SPENCO SILICONE GEL SHEET |
| Classification | Elastomer, Silicone, For Scar Management |
| Applicant | SPENCO MEDICAL CORP. 6301 IMPERIAL DR. Waco, TX 76712 |
| Contact | Brenda Hunt |
| Correspondent | Brenda Hunt SPENCO MEDICAL CORP. 6301 IMPERIAL DR. Waco, TX 76712 |
| Product Code | MDA |
| CFR Regulation Number | 878.4025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-01 |
| Decision Date | 1998-06-25 |