The following data is part of a premarket notification filed by Pneumocare, Inc. with the FDA for Disposable Cannula Tracheostomy Tube, With Inner Cannula;disposable Cannula Fenestrated Tracheostomy Tube, With Inner Cn.
| Device ID | K970811 |
| 510k Number | K970811 |
| Device Name: | DISPOSABLE CANNULA TRACHEOSTOMY TUBE, WITH INNER CANNULA;DISPOSABLE CANNULA FENESTRATED TRACHEOSTOMY TUBE, WITH INNER CN |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | PNEUMOCARE, INC. 23991 IRONHEAD LN. Laguna Niguel, CA 92677 |
| Contact | Joseph H Bales |
| Correspondent | Joseph H Bales PNEUMOCARE, INC. 23991 IRONHEAD LN. Laguna Niguel, CA 92677 |
| Product Code | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-05 |
| Decision Date | 1998-11-13 |
| Summary: | summary |