The following data is part of a premarket notification filed by Interlace Medical, Inc. with the FDA for Myosure Rod Lens Hysteroscope.
| Device ID | K091465 |
| 510k Number | K091465 |
| Device Name: | MYOSURE ROD LENS HYSTEROSCOPE |
| Classification | Hysteroscope (and Accessories) |
| Applicant | INTERLACE MEDICAL, INC. 135 NEWBURY STREET Framingham, MA 01701 |
| Contact | John Vozella |
| Correspondent | John Vozella INTERLACE MEDICAL, INC. 135 NEWBURY STREET Framingham, MA 01701 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-18 |
| Decision Date | 2009-08-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 25420045510323 | K091465 | 000 |
| 15420045510326 | K091465 | 000 |
| 15420045510210 | K091465 | 000 |
| 15420045510203 | K091465 | 000 |