The following data is part of a premarket notification filed by Pharmaseal Laboratories with the FDA for Debrisan (dextranomer) Paste.
| Device ID | K800737 |
| 510k Number | K800737 |
| Device Name: | DEBRISAN (DEXTRANOMER) PASTE |
| Classification | Beads, Hydrophilic, For Wound Exudate Absorption |
| Applicant | PHARMASEAL LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KOZ |
| CFR Regulation Number | 878.4018 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-04-02 |
| Decision Date | 1980-08-04 |