FDA 510(k)

PRE-FILLED SYRINGE W/STERILE 0.9% SODIUM CHLORIDE SOLUTION

K-Number: K943830 · 1994-11-21

Decision Date1994-11-21

Product CodeJOL

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

PRE-FILLED SYRINGE W/STERILE 0.9% SODIUM CHLORIDE SOLUTION is the device name listed in this FDA 510(k) record. The listed applicant is Orion Life Systems, Inc.. It received FDA 510(k) clearance on 1994-11-21 under 510(k) number K943830. 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 PRE-FILLED SYRINGE W/STERILE 0.9% SODIUM CHLORIDE SOLUTION?

PRE-FILLED SYRINGE W/STERILE 0.9% SODIUM CHLORIDE SOLUTION is a medical device that received FDA 510(k) clearance on 1994-11-21. The listed applicant is Orion Life Systems, Inc.. The 510(k) number is K943830.

When did PRE-FILLED SYRINGE W/STERILE 0.9% SODIUM CHLORIDE SOLUTION receive FDA 510(k) clearance?

PRE-FILLED SYRINGE W/STERILE 0.9% SODIUM CHLORIDE SOLUTION received FDA 510(k) clearance on 1994-11-21, under 510(k) number K943830.

Who is the listed applicant for PRE-FILLED SYRINGE W/STERILE 0.9% SODIUM CHLORIDE SOLUTION?

The FDA 510(k) record lists Orion Life Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRE-FILLED SYRINGE W/STERILE 0.9% SODIUM CHLORIDE SOLUTION?

The FDA product code for PRE-FILLED SYRINGE W/STERILE 0.9% SODIUM CHLORIDE SOLUTION is JOL.

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Other records listing Orion Life Systems, Inc. as applicant

K943835PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID K943828STERILE WATER FOR IRRIGATION K943834STERILE .9% SODIUM CHLORIDE SOLUTION K943831PRE-FILLED 30CC INFLATION SYRINGE W/STERILE WATER K943832STERILE .9% SODIUM CHLORIDE FOR IRRATION K943836PRE-FILLED 10CC INFLATION SYRINGE W/STERILE WATER

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Related Devices (Code: JOL)

K051370STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014Baxter Healthcare Corp K000266PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATIONPrimary Care Solutions, Inc.K000265PRIMARY CARE SOLUTIONS STERILE WATER 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

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.