The following data is part of a premarket notification filed by Customed, Inc. with the FDA for Wound Closure/laceration Tray.
| Device ID | K950295 |
| 510k Number | K950295 |
| Device Name: | WOUND CLOSURE/LACERATION TRAY |
| Classification | General Surgery Tray |
| Applicant | CUSTOMED, INC. CALLE IGUALDAD #7 Fajardo, PR 00738 |
| Contact | Felix B Santos |
| Correspondent | Felix B Santos CUSTOMED, INC. CALLE IGUALDAD #7 Fajardo, PR 00738 |
| Product Code | LRO |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-24 |
| Decision Date | 1995-04-18 |