The following data is part of a premarket notification filed by Interlace Medical Inc. with the FDA for Myosure Hysteroscopic Tissue Removal System.
| Device ID | K100559 |
| 510k Number | K100559 |
| Device Name: | MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM |
| Classification | Hysteroscope (and Accessories) |
| Applicant | INTERLACE MEDICAL INC. 135 NEWBURY ST Framingham, MA 01701 |
| Contact | John Vozella |
| Correspondent | John Vozella INTERLACE MEDICAL INC. 135 NEWBURY ST Framingham, MA 01701 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-01 |
| Decision Date | 2010-03-30 |
| Summary: | summary |