The following data is part of a premarket notification filed by Axiom Medical, Inc. with the FDA for Catheters, Drainage.
| Device ID | K771048 |
| 510k Number | K771048 |
| Device Name: | CATHETERS, DRAINAGE |
| Classification | Tube, Double Lumen For Intestinal Decompression And/or Intubation |
| Applicant | AXIOM MEDICAL, INC. 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 | 1977-06-10 |
| Decision Date | 1977-07-19 |