The following data is part of a premarket notification filed by Hill Laboratories Co. with the FDA for Air-flex With Auto-distraction.
| Device ID | K063034 |
| 510k Number | K063034 |
| Device Name: | AIR-FLEX WITH AUTO-DISTRACTION |
| Classification | Table, Physical Therapy, Multi Function |
| Applicant | HILL LABORATORIES CO. 3 N. BACTON HILL RD. Frazer, PA 19355 |
| Contact | Brady Aller |
| Correspondent | Brady Aller HILL LABORATORIES CO. 3 N. BACTON HILL RD. Frazer, PA 19355 |
| Product Code | JFB |
| CFR Regulation Number | 890.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-03 |
| Decision Date | 2006-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860001452525 | K063034 | 000 |