The following data is part of a premarket notification filed by Polygon Medical, Inc. with the FDA for Polygon Resection Device.
| Device ID | K182675 |
| 510k Number | K182675 |
| Device Name: | Polygon Resection Device |
| Classification | Hysteroscope (and Accessories) |
| Applicant | Polygon Medical, Inc. 18 Hillside Drive Holliston, MA 01746 |
| Contact | Ronald Adams |
| Correspondent | Christine Santagate R&Q Solutions 15 Standish Rd Norfolk, MA 02056 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-26 |
| Decision Date | 2019-01-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10860001020608 | K182675 | 000 |