The following data is part of a premarket notification filed by Transidyne General Corp. with the FDA for Primary Surgical Dressing Tray.
| Device ID | K922041 |
| 510k Number | K922041 |
| Device Name: | PRIMARY SURGICAL DRESSING TRAY |
| Classification | Syringe, Piston |
| Applicant | TRANSIDYNE GENERAL CORP. 400 HERALD JOURNAL PARK Spartanburg, SC 29303 |
| Contact | Steven W Butler |
| Correspondent | Steven W Butler TRANSIDYNE GENERAL CORP. 400 HERALD JOURNAL PARK Spartanburg, SC 29303 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-01 |
| Decision Date | 1992-11-06 |