FDA 510(k)

STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014

K-Number: K051370 · 2005-08-12

Decision Date2005-08-12

Product CodeJOL

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014 is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 2005-08-12 under 510(k) number K051370. The device is classified under product code JOL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014?

STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014 is a medical device that received FDA 510(k) clearance on 2005-08-12. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K051370.

When did STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014 receive FDA 510(k) clearance?

STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014 received FDA 510(k) clearance on 2005-08-12, under 510(k) number K051370.

Who is the listed applicant for STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014?

The FDA 510(k) record lists Baxter Healthcare Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014?

The FDA product code for STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014 is JOL.

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Related Devices (Code: JOL)

K000265PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATIONPrimary Care Solutions, Inc.K000266PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATIONPrimary Care Solutions, Inc.K003402WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATIONWelcon, Inc.K994321STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USPAutomatic Liquid Packaging, Inc.K974758HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLEHydrox Laboratories K974759HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLEHydrox Laboratories

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.