NRFit® Caps, Male And Female Neuraxial Tip Caps
Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/or Indirect Cerebral Spinal Fluid Contact
International Medical Industries, Inc.
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.
Pre-market Notification Details
| 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 |
Trademark Results [NRFit]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
NRFIT 86688062 not registered Live/Pending |
Global Enteral Device Supplier Association, Inc. 2015-07-09 |
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