The following data is part of a premarket notification filed by Biodermis Corp. with the FDA for Epi-foam Silicone Sheeting.
| Device ID | K991604 |
| 510k Number | K991604 |
| Device Name: | EPI-FOAM SILICONE SHEETING |
| Classification | Elastomer, Silicone, For Scar Management |
| Applicant | BIODERMIS CORP. 3078 EAST SUNSET RD. SUITE #1 Las Vegas, NV 89120 |
| Contact | Jeff S Schleuning |
| Correspondent | Jeff S Schleuning BIODERMIS CORP. 3078 EAST SUNSET RD. SUITE #1 Las Vegas, NV 89120 |
| Product Code | MDA |
| CFR Regulation Number | 878.4025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-10 |
| Decision Date | 1999-06-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854763005822 | K991604 | 000 |
| 00852260000869 | K991604 | 000 |
| 00852260000432 | K991604 | 000 |
| 00854763005990 | K991604 | 000 |
| 00854763005983 | K991604 | 000 |
| 00854763005853 | K991604 | 000 |
| 00854763005846 | K991604 | 000 |
| 00854763005839 | K991604 | 000 |
| 00850014883133 | K991604 | 000 |
| 00854763005525 | K991604 | 000 |
| 00854763005532 | K991604 | 000 |
| 00854763005815 | K991604 | 000 |
| 00854763005808 | K991604 | 000 |
| 00854763005792 | K991604 | 000 |
| 00854763005785 | K991604 | 000 |
| 00854763005778 | K991604 | 000 |
| 00854763005761 | K991604 | 000 |
| 00854763005754 | K991604 | 000 |
| 00854763005549 | K991604 | 000 |
| 00850014883126 | K991604 | 000 |