The following data is part of a premarket notification filed by Sorex Medical with the FDA for Graft Guard.
| Device ID | K885136 |
| 510k Number | K885136 |
| Device Name: | GRAFT GUARD |
| Classification | Guard, Skin Graft |
| Applicant | SOREX MEDICAL 2955 SOUTH MAIN ST. Salt Lake City, UT 84115 |
| Contact | Reed F Winterton |
| Correspondent | Reed F Winterton SOREX MEDICAL 2955 SOUTH MAIN ST. Salt Lake City, UT 84115 |
| Product Code | LZM |
| CFR Regulation Number | 878.4014 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-15 |
| Decision Date | 1989-02-06 |