The following data is part of a premarket notification filed by Augustine Medical, Inc. with the FDA for Model 90022 Rolling Stand.
| Device ID | K963672 |
| 510k Number | K963672 |
| Device Name: | MODEL 90022 ROLLING STAND |
| Classification | Sleeve, Limb, Compressible |
| Applicant | AUGUSTINE MEDICAL, INC. 10393 WEST 70TH ST. Eden Prairie, MN 55344 |
| Contact | Scott D Augustine, M.d. |
| Correspondent | Scott D Augustine, M.d. AUGUSTINE MEDICAL, INC. 10393 WEST 70TH ST. Eden Prairie, MN 55344 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-13 |
| Decision Date | 1997-01-06 |
| Summary: | summary |