The following data is part of a premarket notification filed by Arjohuntleigh Inc with the FDA for Parker 500.
| Device ID | K110994 |
| 510k Number | K110994 |
| Device Name: | PARKER 500 |
| Classification | Bath, Hydro-massage |
| Applicant | ARJOHUNTLEIGH INC 2349 WEST LAKE STREET SUITE 250 Addison, IL 60101 |
| Contact | Brenda Ammonette |
| Correspondent | Brenda Ammonette ARJOHUNTLEIGH INC 2349 WEST LAKE STREET SUITE 250 Addison, IL 60101 |
| Product Code | ILJ |
| CFR Regulation Number | 890.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-08 |
| Decision Date | 2011-07-06 |
| Summary: | summary |