The following data is part of a premarket notification filed by Trinity Laboratories, Inc. with the FDA for Tracheostomy Care Kit, Sterile, Disposable.
| Device ID | K920281 |
| 510k Number | K920281 |
| Device Name: | TRACHEOSTOMY CARE KIT, STERILE, DISPOSABLE |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | TRINITY LABORATORIES, INC. P.O. BOX 4458 201 KILEY DRIVE Salisbury, MD 21803 |
| Contact | Partha Basumallik |
| Correspondent | Partha Basumallik TRINITY LABORATORIES, INC. P.O. BOX 4458 201 KILEY DRIVE Salisbury, MD 21803 |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-22 |
| Decision Date | 1992-08-27 |