The following data is part of a premarket notification filed by Smith & Nephew Inc., Endoscopy Division with the FDA for Gynecology Sterilization Tray.
| Device ID | K121904 |
| 510k Number | K121904 |
| Device Name: | GYNECOLOGY STERILIZATION TRAY |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | SMITH & NEPHEW INC., ENDOSCOPY DIVISION 150 Minuteman Rd Andover, MA 01810 |
| Contact | Janice Haselton |
| Correspondent | Janice Haselton SMITH & NEPHEW INC., ENDOSCOPY DIVISION 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 | 2012-06-29 |
| Decision Date | 2013-03-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885554018400 | K121904 | 000 |
| 10884521744158 | K121904 | 000 |