The following data is part of a premarket notification filed by Dynarex Corp. with the FDA for Dynarex Suction Catheters & Kits.
| Device ID | K922843 |
| 510k Number | K922843 |
| Device Name: | DYNAREX SUCTION CATHETERS & KITS |
| Classification | Catheters, Suction, Tracheobronchial |
| Applicant | DYNAREX CORP. ONE INTERNATIONAL BLVD. Brewster, NY 10509 |
| Contact | Randell Green |
| Correspondent | Randell Green DYNAREX CORP. ONE INTERNATIONAL BLVD. Brewster, NY 10509 |
| Product Code | BSY |
| CFR Regulation Number | 868.6810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-12 |
| Decision Date | 1993-01-11 |