The following data is part of a premarket notification filed by Procyte Corp. with the FDA for Lamin-2 Hydrating Gel.
| Device ID | K970153 |
| 510k Number | K970153 |
| Device Name: | LAMIN-2 HYDRATING GEL |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | PROCYTE CORP. 12040 115TH AVE. N.E., #210 Kirkland, WA 98034 |
| Contact | Paul Ketteridge |
| Correspondent | Paul Ketteridge PROCYTE CORP. 12040 115TH AVE. N.E., #210 Kirkland, WA 98034 |
| Product Code | MGQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-16 |
| Decision Date | 1997-06-05 |
| Summary: | summary |