The following data is part of a premarket notification filed by Cui Corp. with the FDA for Silicone Gel Sheeting.
| Device ID | K913140 |
| 510k Number | K913140 |
| Device Name: | SILICONE GEL SHEETING |
| Classification | Elastomer, Silicone, For Scar Management |
| Applicant | CUI CORP. P.O. BOX 40288 Santa Barbara, CA 93140 |
| Contact | Ellen Duke |
| Correspondent | Ellen Duke CUI CORP. P.O. BOX 40288 Santa Barbara, CA 93140 |
| Product Code | MDA |
| CFR Regulation Number | 878.4025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-16 |
| Decision Date | 1991-09-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00768627007146 | K913140 | 000 |
| 00768627007139 | K913140 | 000 |
| 00768627007122 | K913140 | 000 |
| 00768627007108 | K913140 | 000 |
| 00768627007092 | K913140 | 000 |
| 00768627007085 | K913140 | 000 |
| 00768627007078 | K913140 | 000 |