The following data is part of a premarket notification filed by Bio Med Sciences, Inc. with the FDA for Silon Dual-dress.
| Device ID | K990042 |
| 510k Number | K990042 |
| Device Name: | SILON DUAL-DRESS |
| Classification | Dressing, Wound And Burn, Occlusive |
| 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 | MGP |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-06 |
| Decision Date | 1999-03-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10810050460115 | K990042 | 000 |
| 10810050460108 | K990042 | 000 |