The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Mentor H/s Silicone Gel Sheeting For Scar Management.
| Device ID | K962013 |
| 510k Number | K962013 |
| Device Name: | MENTOR H/S SILICONE GEL SHEETING FOR SCAR MANAGEMENT |
| Classification | Elastomer, Silicone, For Scar Management |
| Applicant | MENTOR CORP. 5425 HOLLISTER AVE. Santa Barbara, CA 93111 |
| Contact | Lynn Breckenridge |
| Correspondent | Lynn Breckenridge MENTOR CORP. 5425 HOLLISTER AVE. Santa Barbara, CA 93111 |
| Product Code | MDA |
| CFR Regulation Number | 878.4025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-23 |
| Decision Date | 1996-08-22 |
| Summary: | summary |