The following data is part of a premarket notification filed by Symmetry Surgical Inc. with the FDA for Symmetry Surgical Quad-lock Container System.
Device ID | K152111 |
510k Number | K152111 |
Device Name: | Symmetry Surgical Quad-Lock Container System |
Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
Applicant | SYMMETRY SURGICAL INC. 334 OWEN DRIVE Antioch, TN 37013 |
Contact | Lora Tjomstol |
Correspondent | Michele Lucey LAKESHORE MEDICAL DEVICE CONSULTING LLC 128 BLYE HILL LANDING Newbury, NH 03255 |
Product Code | KCT |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-07-29 |
Decision Date | 2016-04-14 |
Summary: | summary |