The following data is part of a premarket notification filed by Symmetry Surgical Inc. with the FDA for Ergonomic Handle.
Device ID | K173272 |
510k Number | K173272 |
Device Name: | Ergonomic Handle |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | Symmetry Surgical Inc. 3034 Owen Drive Antioch, TN 37013 |
Contact | Christopher Smith |
Correspondent | Christopher Smith Symmetry Surgical Inc. 3034 Owen Drive Antioch, TN 37013 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-10-12 |
Decision Date | 2018-02-09 |
Summary: | summary |