The following data is part of a premarket notification filed by Procyte Corp. with the FDA for Iamin Gel Wound Dressing.
| Device ID | K953853 |
| 510k Number | K953853 |
| Device Name: | IAMIN GEL WOUND DRESSING |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | PROCYTE CORP. 12040 115TH AVENUE NE SUITE 210 Kirkland, WA 98034 |
| Contact | David J Dempsey |
| Correspondent | David J Dempsey PROCYTE CORP. 12040 115TH AVENUE NE SUITE 210 Kirkland, WA 98034 |
| Product Code | MGQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-16 |
| Decision Date | 1996-02-05 |