The following data is part of a premarket notification filed by Transidyne General Corp. with the FDA for Laceration Tray.
| Device ID | K955658 |
| 510k Number | K955658 |
| Device Name: | LACERATION TRAY |
| Classification | Wrap, Sterilization |
| 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 | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-12 |
| Decision Date | 1996-01-25 |