The following data is part of a premarket notification filed by International Medical Industries, Inc. with the FDA for Nrfit® Caps, Male And Female Neuraxial Tip Caps.
Device ID | K201031 |
510k Number | K201031 |
Device Name: | NRFit® Caps, Male And Female Neuraxial Tip Caps |
Classification | Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/or Indirect Cerebral Spinal Fluid Contact |
Applicant | International Medical Industries, Inc. 2981 Gateway Drive Pompano Beach, FL 33069 |
Contact | David Melly |
Correspondent | David Meily International Medical Industries, Inc. 2981 Gateway Drive Pompano Beach, FL 33069 |
Product Code | QEH |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-04-20 |
Decision Date | 2020-12-16 |
Mark Image Registration | Serial | Company Trademark Application Date |
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![]() NRFIT 86688062 not registered Live/Pending |
Global Enteral Device Supplier Association, Inc. 2015-07-09 |