The following data is part of a premarket notification filed by Bio Med Sciences, Inc. with the FDA for Silon(r) Silicone Thermoplastic Sheeting.
| Device ID | K945892 |
| 510k Number | K945892 |
| Device Name: | SILON(R) SILICONE THERMOPLASTIC 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 | 1994-12-02 |
| Decision Date | 1995-03-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10810050460658 | K945892 | 000 |
| 10810050460641 | K945892 | 000 |
| 10810050460634 | K945892 | 000 |