The following data is part of a premarket notification filed by Trinity Laboratories, Inc. with the FDA for Dressing Change Tray, Sterile, Disposable.
| Device ID | K921394 |
| 510k Number | K921394 |
| Device Name: | DRESSING CHANGE TRAY, STERILE, DISPOSABLE |
| Classification | Drape, Surgical |
| Applicant | TRINITY LABORATORIES, INC. 201 KILEY DR. Salisbury, MD 21801 |
| Contact | Partha Basumallik |
| Correspondent | Partha Basumallik TRINITY LABORATORIES, INC. 201 KILEY DR. Salisbury, MD 21801 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-23 |
| Decision Date | 1992-08-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20885632146722 | K921394 | 000 |
| 50885632136595 | K921394 | 000 |
| 50885632134928 | K921394 | 000 |
| 50885632127692 | K921394 | 000 |
| 50885632111349 | K921394 | 000 |
| 50885632109636 | K921394 | 000 |
| 50885632109179 | K921394 | 000 |
| 50885632109155 | K921394 | 000 |
| 50885632109001 | K921394 | 000 |
| 50885632136670 | K921394 | 000 |
| 50885632137301 | K921394 | 000 |
| 20885632141345 | K921394 | 000 |
| 20885632146715 | K921394 | 000 |
| 20885632144018 | K921394 | 000 |
| 20885632141796 | K921394 | 000 |
| 20885632141420 | K921394 | 000 |
| 20885632141413 | K921394 | 000 |
| 20885632141390 | K921394 | 000 |
| 20885632141376 | K921394 | 000 |
| 20885632141369 | K921394 | 000 |
| 50885632108936 | K921394 | 000 |