The following data is part of a premarket notification filed by Lake Medical Products, Inc. with the FDA for Lake Ostomy Care Set.
| Device ID | K922730 |
| 510k Number | K922730 |
| Device Name: | LAKE OSTOMY CARE SET |
| Classification | Collector, Ostomy |
| 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 | EXB |
| CFR Regulation Number | 876.5900 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-05 |
| Decision Date | 1993-12-30 |