The following data is part of a premarket notification filed by Ideal Medical, Inc. with the FDA for Reddick Irrigation/aspiration System.
| Device ID | K910117 |
| 510k Number | K910117 |
| Device Name: | REDDICK IRRIGATION/ASPIRATION SYSTEM |
| Classification | Needle, Aspiration And Injection, Disposable |
| Applicant | IDEAL MEDICAL, INC. 12167 49TH ST. NORTH P.O. BOX 17327 Clearwater, FL 34622 |
| Contact | Lorna Linville |
| Correspondent | Lorna Linville IDEAL MEDICAL, INC. 12167 49TH ST. NORTH P.O. BOX 17327 Clearwater, FL 34622 |
| Product Code | GAA |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-11 |
| Decision Date | 1991-03-19 |