The following data is part of a premarket notification filed by Biodermis Corp. with the FDA for Cryosil Silicone Gel Sheeting.
| Device ID | K964047 |
| 510k Number | K964047 |
| Device Name: | CRYOSIL SILICONE GEL SHEETING |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | BIODERMIS CORP. 3753 HOWARD HUGHES PARKWAY, SUITE #310 Las Vegas, NV 89109 |
| Contact | Dennis A Repella |
| Correspondent | Dennis A Repella BIODERMIS CORP. 3753 HOWARD HUGHES PARKWAY, SUITE #310 Las Vegas, NV 89109 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-09 |
| Decision Date | 1997-03-19 |