The following data is part of a premarket notification filed by Medco Instruments, Inc. with the FDA for Laceration Tray.
| Device ID | K960520 |
| 510k Number | K960520 |
| Device Name: | LACERATION TRAY |
| Classification | Wrap, Sterilization |
| Applicant | MEDCO INSTRUMENTS, INC. C/O BURDITT & RADZIUS 333 WEST WACKER DR., STE. 2600 Chicago, IL 60606 |
| Contact | Richard O Wood |
| Correspondent | Richard O Wood MEDCO INSTRUMENTS, INC. C/O BURDITT & RADZIUS 333 WEST WACKER DR., STE. 2600 Chicago, IL 60606 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-06 |
| Decision Date | 1996-03-21 |
| Summary: | summary |