The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Hodge Tube.
Device ID | K772282 |
510k Number | K772282 |
Device Name: | HODGE TUBE |
Classification | Tube, Double Lumen For Intestinal Decompression And/or Intubation |
Applicant | MALLINCKRODT CRITICAL CARE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FEG |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-12-12 |
Decision Date | 1978-03-09 |