The following data is part of a premarket notification filed by Applied Medical Resources with the FDA for Tracheostomy Tube And Tube Cuff.
| Device ID | K924660 |
| 510k Number | K924660 |
| Device Name: | TRACHEOSTOMY TUBE AND TUBE CUFF |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 Laguna Hills, CA 92653 |
| Contact | Jo Stegwell |
| Correspondent | Jo Stegwell APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 Laguna Hills, CA 92653 |
| Product Code | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-15 |
| Decision Date | 1992-12-11 |