The following data is part of a premarket notification filed by Inmed Corp. with the FDA for Hodge Decompression Tube.
Device ID | K834258 |
510k Number | K834258 |
Device Name: | HODGE DECOMPRESSION TUBE |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | INMED CORP. 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 | 1983-12-07 |
Decision Date | 1984-02-04 |