The following data is part of a premarket notification filed by Kendall Healthcare Products Co. Div.of Tyco Health with the FDA for Kendall Sher-i-bronch Endobrochial Tube.
| Device ID | K961977 |
| 510k Number | K961977 |
| Device Name: | KENDALL SHER-I-BRONCH ENDOBROCHIAL TUBE |
| Classification | Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) |
| Applicant | KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Contact | David A Olson |
| Correspondent | David A Olson KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Product Code | CBI |
| CFR Regulation Number | 868.5740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-20 |
| Decision Date | 1996-07-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 34026704617426 | K961977 | 000 |
| 24026704397604 | K961977 | 000 |
| 24026704397611 | K961977 | 000 |
| 44026704397622 | K961977 | 000 |
| 24026704397635 | K961977 | 000 |
| 44026704617386 | K961977 | 000 |
| 44026704617393 | K961977 | 000 |
| 44026704617409 | K961977 | 000 |
| 44026704617416 | K961977 | 000 |
| 44026704397592 | K961977 | 000 |