The following data is part of a premarket notification filed by Rusch Intl. with the FDA for Rusch Endobronchial Tube Sets.
| Device ID | K951091 |
| 510k Number | K951091 |
| Device Name: | RUSCH ENDOBRONCHIAL TUBE SETS |
| Classification | Tube, Bronchial (w/wo Connector) |
| Applicant | RUSCH INTL. TALL PINES PARK Jaffrey, NH 03452 |
| Contact | Neil R Armstrong |
| Correspondent | Neil R Armstrong RUSCH INTL. TALL PINES PARK Jaffrey, NH 03452 |
| Product Code | BTS |
| CFR Regulation Number | 868.5720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-09 |
| Decision Date | 1995-06-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04026704009398 | K951091 | 000 |
| 04026704009381 | K951091 | 000 |
| 04026704009374 | K951091 | 000 |
| 04026704009367 | K951091 | 000 |
| 04026704008841 | K951091 | 000 |
| 04026704008834 | K951091 | 000 |
| 04026704008827 | K951091 | 000 |
| 04026704008810 | K951091 | 000 |
| 14026704065261 | K951091 | 000 |