The following data is part of a premarket notification filed by Ideal Medical, Inc. with the FDA for Grice Foot Pedal Control/reddick Irri/aspir Syst.
Device ID | K914913 |
510k Number | K914913 |
Device Name: | GRICE FOOT PEDAL CONTROL/REDDICK IRRI/ASPIR SYST |
Classification | Clamp, Surgical, General & Plastic Surgery |
Applicant | IDEAL MEDICAL, INC. 12167 49TH ST. NORTH P.O. BOX 17327 Clearwater, FL 34622 |
Contact | Lorna K Linville |
Correspondent | Lorna K Linville IDEAL MEDICAL, INC. 12167 49TH ST. NORTH P.O. BOX 17327 Clearwater, FL 34622 |
Product Code | GDJ |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-11-01 |
Decision Date | 1991-12-31 |