The following data is part of a premarket notification filed by Bio Med Sciences, Inc. with the FDA for Silon Silicone Foam Sheeting.
| Device ID | K946362 |
| 510k Number | K946362 |
| Device Name: | SILON SILICONE FOAM SHEETING |
| Classification | Elastomer, Silicone, For Scar Management |
| Applicant | BIO MED SCIENCES, INC. 101 TECHNOLOGY DR. Bethlehem, PA 18015 |
| Contact | Mark E Dillon |
| Correspondent | Mark E Dillon BIO MED SCIENCES, INC. 101 TECHNOLOGY DR. Bethlehem, PA 18015 |
| Product Code | MDA |
| CFR Regulation Number | 878.4025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-08 |
| Decision Date | 1995-07-13 |