The following data is part of a premarket notification filed by Procyte Corp. with the FDA for Osmocyte Ultra/pe Pillow Wound Dressing.
| Device ID | K962623 |
| 510k Number | K962623 |
| Device Name: | OSMOCYTE ULTRA/PE PILLOW WOUND DRESSING |
| Classification | Bandage, Liquid |
| Applicant | PROCYTE CORP. 12040 115TH AVENUE NE SUITE 210 Kirkland, WA 98034 |
| Contact | Paul Ketteridge |
| Correspondent | Paul Ketteridge PROCYTE CORP. 12040 115TH AVENUE NE SUITE 210 Kirkland, WA 98034 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-05 |
| Decision Date | 1996-11-26 |
| Summary: | summary |