The following data is part of a premarket notification filed by Bio Med Sciences, Inc. with the FDA for Silon Transparent Wound Dressings.
Device ID | K923150 |
510k Number | K923150 |
Device Name: | SILON TRANSPARENT WOUND DRESSINGS |
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 | 1992-06-29 |
Decision Date | 1992-08-27 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10810050460054 | K923150 | 000 |
10810050460047 | K923150 | 000 |
10810050460023 | K923150 | 000 |
10810050460016 | K923150 | 000 |
10810050460030 | K923150 | 000 |