The following data is part of a premarket notification filed by Macpherson Medical, Inc. with the FDA for Stat-mat Minor.
| Device ID | K110500 |
| 510k Number | K110500 |
| Device Name: | STAT-MAT MINOR |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | MACPHERSON MEDICAL, INC. 555 13TH STREET, NW COLUMBIA SQUARE Washington, DC 20004 |
| Contact | Howard Holstein |
| Correspondent | Howard Holstein MACPHERSON MEDICAL, INC. 555 13TH STREET, NW COLUMBIA SQUARE Washington, DC 20004 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-22 |
| Decision Date | 2011-06-23 |
| Summary: | summary |