The following data is part of a premarket notification filed by Apdyne Medical Co. with the FDA for Hygiena-trach.
| Device ID | K911080 |
| 510k Number | K911080 |
| Device Name: | HYGIENA-TRACH |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | APDYNE MEDICAL CO. 955 WEST IDAHO AVE. Saint Paul, MN 55117 |
| Contact | Michael W Walsh |
| Correspondent | Michael W Walsh APDYNE MEDICAL CO. 955 WEST IDAHO AVE. Saint Paul, MN 55117 |
| Product Code | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-11 |
| Decision Date | 1991-05-20 |