The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Iur Reciprocating Morcellator Model # 7210517.
| Device ID | K041774 |
| 510k Number | K041774 |
| Device Name: | IUR RECIPROCATING MORCELLATOR MODEL # 7210517 |
| Classification | Hysteroscope (and Accessories) |
| Applicant | SMITH & NEPHEW, INC. 150 Minuteman Road Andover, MA 01810 |
| Contact | Janice Haselton |
| Correspondent | Janice Haselton SMITH & NEPHEW, INC. 150 Minuteman Road 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 | 2004-07-01 |
| Decision Date | 2004-10-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885554027617 | K041774 | 000 |