The following data is part of a premarket notification filed by Lake Medical Products, Inc. with the FDA for Lake Gastrostomy Tube.
| Device ID | K902121 |
| 510k Number | K902121 |
| Device Name: | LAKE GASTROSTOMY TUBE |
| Classification | Tube, Gastro-enterostomy |
| 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 | KGC |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-11 |
| Decision Date | 1990-07-27 |