The following data is part of a premarket notification filed by Adhezion Biomedical with the FDA for Floraseal, Model Fs350d.
| Device ID | K083354 |
| 510k Number | K083354 |
| Device Name: | FLORASEAL, MODEL FS350D |
| Classification | Sealant, Microbial |
| Applicant | ADHEZION BIOMEDICAL 506 PINE MOUNTAIN RD Hudson, NC 28638 |
| Contact | Richard Jones |
| Correspondent | Richard Jones ADHEZION BIOMEDICAL 506 PINE MOUNTAIN RD Hudson, NC 28638 |
| Product Code | NZP |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-13 |
| Decision Date | 2009-07-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M495FS035T0 | K083354 | 000 |