The following data is part of a premarket notification filed by Turbett Surgical Llc with the FDA for Turbett Surgical Container.
Device ID | K153025 |
510k Number | K153025 |
Device Name: | Turbett Surgical Container |
Classification | Wrap, Sterilization |
Applicant | TURBETT SURGICAL LLC 125 TECH PARK DRIVE SUITE 2108 Rochester, NY 14623 |
Contact | Rob Turbett |
Correspondent | David Furr FDC Services 8708 CAPEHART COVE Austin, TX 78733 |
Product Code | FRG |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-10-16 |
Decision Date | 2016-01-14 |
Summary: | summary |