The following data is part of a premarket notification filed by Bio Med Sciences, Inc. with the FDA for Silon(tm) Transparent Wound Dressing.
| Device ID | K912032 |
| 510k Number | K912032 |
| Device Name: | SILON(TM) TRANSPARENT WOUND DRESSING |
| Classification | Dressing, Wound And Burn, Occlusive |
| Applicant | BIO MED SCIENCES, INC. 115 RESEARCH DR. Bethlehem, PA 18015 |
| Contact | Mark E Dillon |
| Correspondent | Mark E Dillon BIO MED SCIENCES, INC. 115 RESEARCH 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 | 1991-05-08 |
| Decision Date | 1991-08-20 |