The following data is part of a premarket notification filed by Robinson Medsurg Llc with the FDA for Robinson Medsurg Quickscrew Rack.
Device ID | K093800 |
510k Number | K093800 |
Device Name: | ROBINSON MEDSURG QUICKSCREW RACK |
Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
Applicant | ROBINSON MEDSURG LLC 7430 E. PARK MEADOWS DR. SUITE 300 Lone Tree, CO 80124 |
Contact | Randolph C Robinson |
Correspondent | Randolph C Robinson ROBINSON MEDSURG LLC 7430 E. PARK MEADOWS DR. SUITE 300 Lone Tree, CO 80124 |
Product Code | KCT |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-12-10 |
Decision Date | 2010-06-16 |
Summary: | summary |