The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Stomach Tube Levin Tube.
Device ID | K831974 |
510k Number | K831974 |
Device Name: | STOMACH TUBE LEVIN TUBE |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | MEDLINE INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-06-20 |
Decision Date | 1983-07-18 |