The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Iur Morcellation System.
| Device ID | K031787 |
| 510k Number | K031787 |
| Device Name: | SMITH & NEPHEW IUR MORCELLATION SYSTEM |
| Classification | Hysteroscope (and Accessories) |
| Applicant | SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover, MA 01810 |
| Contact | Janice Haselton |
| Correspondent | Janice Haselton SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover, MA 01810 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-10 |
| Decision Date | 2003-12-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521749931 | K031787 | 000 |
| 10884521746671 | K031787 | 000 |
| 10884521746664 | K031787 | 000 |