The following data is part of a premarket notification filed by Interlace Medical, Inc. with the FDA for Interlace Medical Operative Hysteroscopy System.
| Device ID | K081070 |
| 510k Number | K081070 |
| Device Name: | INTERLACE MEDICAL OPERATIVE HYSTEROSCOPY SYSTEM |
| Classification | Hysteroscope (and Accessories) |
| Applicant | INTERLACE MEDICAL, INC. 139 NEWBURY STREET Framingham, MA 01701 |
| Contact | Ron Adams |
| Correspondent | Ron Adams INTERLACE MEDICAL, INC. 139 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 | 2008-04-15 |
| Decision Date | 2008-07-23 |
| Summary: | summary |