The following data is part of a premarket notification filed by Arch Development Group with the FDA for Stasis Button Prssure Device.
| Device ID | K912765 |
| 510k Number | K912765 |
| Device Name: | STASIS BUTTON PRSSURE DEVICE |
| Classification | Dressing, Compression |
| Applicant | ARCH DEVELOPMENT GROUP 9648 OLIVE BLVD., SUITE 411 St. Louis, MO 63132 |
| Contact | Robert A Roth |
| Correspondent | Robert A Roth ARCH DEVELOPMENT GROUP 9648 OLIVE BLVD., SUITE 411 St. Louis, MO 63132 |
| Product Code | MHW |
| CFR Regulation Number | 880.5075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-24 |
| Decision Date | 1991-08-12 |