The following data is part of a premarket notification filed by Superior Healthcare Group, Inc. with the FDA for No. 34100 - 8 Fr & No. 34400 - 14 Fr Closed Trach..
| Device ID | K896321 |
| 510k Number | K896321 |
| Device Name: | NO. 34100 - 8 FR & NO. 34400 - 14 FR CLOSED TRACH. |
| Classification | Catheters, Suction, Tracheobronchial |
| Applicant | SUPERIOR HEALTHCARE GROUP, INC. CUMBERLAND INDUSTRIAL PARK Cumberland, RI 02864 |
| Contact | Paul Bernard |
| Correspondent | Paul Bernard SUPERIOR HEALTHCARE GROUP, INC. CUMBERLAND INDUSTRIAL PARK Cumberland, RI 02864 |
| Product Code | BSY |
| CFR Regulation Number | 868.6810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-01 |
| Decision Date | 1989-11-13 |