HUDSON RCI ADDIPAK UNIT DOSE VIAL, 0.9% FULL NORMAL SALINE SOLUTION, 3ML;5ML;15ML

Nebulizer (direct Patient Interface)

Teleflex Medical, Inc.

The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for Hudson Rci Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution, 3ml;5ml;15ml.

Pre-market Notification Details

• Device ID: K142153
• 510k Number: K142153
• Device Name: HUDSON RCI ADDIPAK UNIT DOSE VIAL, 0.9% FULL NORMAL SALINE SOLUTION, 3ML;5ML;15ML
• Classification: Nebulizer (direct Patient Interface)
• Applicant: Teleflex Medical, Inc. 2917 WECK DR. Research Triangle Park, NC 27709
• Contact: James A Cochie
• Correspondent: James A Cochie; Teleflex Medical, Inc. 2917 WECK DR. Research Triangle Park, NC 27709
• Product Code: CAF
• CFR Regulation Number: 868.5630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-08-06
• Decision Date: 2015-04-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
24026704597424	K142153	000
44026704628146	K142153	000
34026704717812	K142153	000
30197344008128	K142153	000