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 | K091100 |
| 510k Number | K091100 |
| Device Name: | MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM |
| Classification | Hysteroscope (and Accessories) |
| Applicant | INTERLACE MEDICAL, INC. 555 THIRTEEN STREET, N.W. Washington, DC 20010 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan INTERLACE MEDICAL, INC. 555 THIRTEEN STREET, N.W. Washington, DC 20010 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-16 |
| Decision Date | 2009-10-23 |
| Summary: | summary |