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FDA 510(k)

PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID

K-Number: K943835 · 1995-01-24

ApplicantOrion Life Systems, Inc.
Decision Date1995-01-24
Product CodeKNY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID 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 1995-01-24 under 510(k) number K943835. The device is classified under product code KNY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID?

PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID is a medical device that received FDA 510(k) clearance on 1995-01-24. The listed applicant is Orion Life Systems, Inc.. The 510(k) number is K943835.

When did PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID receive FDA 510(k) clearance?

PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID received FDA 510(k) clearance on 1995-01-24, under 510(k) number K943835.

Who is the listed applicant for PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID?

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 .25% ACETC ACID?

The FDA product code for PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID is KNY.

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Other records listing Orion Life Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K943830PRE-FILLED SYRINGE W/STERILE 0.9% SODIUM CHLORIDE SOLUTIONK943828STERILE WATER FOR IRRIGATIONK943834STERILE .9% SODIUM CHLORIDE SOLUTIONK943831PRE-FILLED 30CC INFLATION SYRINGE W/STERILE WATERK943832STERILE .9% SODIUM CHLORIDE FOR IRRATIONK943836PRE-FILLED 10CC INFLATION SYRINGE W/STERILE WATER

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Related Devices (Code: KNY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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