The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Instrument Trays.
| Device ID | K090562 |
| 510k Number | K090562 |
| Device Name: | SMITH & NEPHEW INSTRUMENT TRAYS |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | SMITH & NEPHEW, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
| Contact | Julie Acker |
| Correspondent | Julie Acker SMITH & NEPHEW, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-02 |
| Decision Date | 2009-03-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556659304 | K090562 | 000 |
| 00885554015416 | K090562 | 000 |
| 00885554015010 | K090562 | 000 |
| 03596010621979 | K090562 | 000 |
| 03596010621344 | K090562 | 000 |
| 03596010610270 | K090562 | 000 |