The following data is part of a premarket notification filed by Hill-rom, Inc. with the FDA for Vollman Prone Positioner.
| Device ID | K963091 |
| 510k Number | K963091 |
| Device Name: | VOLLMAN PRONE POSITIONER |
| Classification | Orthosis, Thoracic |
| Applicant | HILL-ROM, INC. 4349 CORPORATE RD. Charleston, SC 29405 |
| Contact | Edwin L Bills |
| Correspondent | Edwin L Bills HILL-ROM, INC. 4349 CORPORATE RD. Charleston, SC 29405 |
| Product Code | IPT |
| CFR Regulation Number | 890.3490 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-08 |
| Decision Date | 1997-01-09 |
| Summary: | summary |