The following data is part of a premarket notification filed by Rusch, Inc. with the FDA for Rusch Agt Pvc Preform Nasal Trach Tub/cuf W/mur Ey.
| Device ID | K931164 |
| 510k Number | K931164 |
| Device Name: | RUSCH AGT PVC PREFORM NASAL TRACH TUB/CUF W/MUR EY |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | RUSCH, INC. TALL PINES PARK Jaffrey, NH 03452 |
| Contact | Richard T Lykins |
| Correspondent | Richard T Lykins RUSCH, INC. TALL PINES PARK Jaffrey, NH 03452 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-08 |
| Decision Date | 1993-06-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 24026704341249 | K931164 | 000 |
| 44026704341168 | K931164 | 000 |
| 44026704341175 | K931164 | 000 |
| 44026704341182 | K931164 | 000 |
| 24026704341195 | K931164 | 000 |
| 24026704341201 | K931164 | 000 |
| 24026704341218 | K931164 | 000 |
| 24026704341225 | K931164 | 000 |
| 24026704341232 | K931164 | 000 |
| 24026704341157 | K931164 | 000 |