The following data is part of a premarket notification filed by Lake Medical Products, Inc. with the FDA for Lake Foley Catheterization Tray.
| Device ID | K883610 |
| 510k Number | K883610 |
| Device Name: | LAKE FOLEY CATHETERIZATION TRAY |
| Classification | Urinary Drainage Collection Kit, For Indwelling Catheter |
| Applicant | LAKE MEDICAL PRODUCTS, INC. 1145 MOOG DR. St. Louis, MO 63146 |
| Contact | Eli Schachet |
| Correspondent | Eli Schachet LAKE MEDICAL PRODUCTS, INC. 1145 MOOG DR. St. Louis, MO 63146 |
| Product Code | FCN |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-22 |
| Decision Date | 1988-10-12 |