The following data is part of a premarket notification filed by Gri Medical And Electronic Technology Co., Ltd. with the FDA for Gri-alleset Veress Needle.
| Device ID | K172835 |
| 510k Number | K172835 |
| Device Name: | GRI-Alleset Veress Needle |
| Classification | Insufflator, Laparoscopic |
| Applicant | GRI Medical And Electronic Technology Co., Ltd. 105 Honggao Road, Xiuzhou Industry Zone Jiaxing, CN 314031 |
| Contact | Martin Paugh |
| Correspondent | Sharon Marrow Sharon Marrow 2907 Cherry Branch Drive Knoxville, TN 37948 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-19 |
| Decision Date | 2018-06-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06931918163416 | K172835 | 000 |
| 06931918138681 | K172835 | 000 |
| 26931918181520 | K172835 | 000 |