The following data is part of a premarket notification filed by Lake Medical Products, Inc. with the FDA for Lake N/g Feeding Tube (with Y Port Connector).
Device ID | K901835 |
510k Number | K901835 |
Device Name: | LAKE N/G FEEDING TUBE (WITH Y PORT CONNECTOR) |
Classification | Tubes, Gastrointestinal (and Accessories) |
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 | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-04-19 |
Decision Date | 1990-09-05 |