The following data is part of a premarket notification filed by Smith & Nephew Inc., Endoscopy Div. with the FDA for Smith & Nephew Instrument Trays.
| Device ID | K092551 |
| 510k Number | K092551 |
| Device Name: | SMITH & NEPHEW INSTRUMENT TRAYS |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | SMITH & NEPHEW INC., ENDOSCOPY DIV. 150 MINUTEMAN RD. Andover, MA 01810 |
| Contact | Christina Flores |
| Correspondent | Christina Flores SMITH & NEPHEW INC., ENDOSCOPY DIV. 150 MINUTEMAN RD. Andover, MA 01810 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-20 |
| Decision Date | 2010-09-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556573167 | K092551 | 000 |
| 03596010651259 | K092551 | 000 |
| 00885556818343 | K092551 | 000 |