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FDA 510(k)

PRE-FILLED 10CC INFLATION SYRINGE W/STERILE WATER

K-Number: K943836 · 1994-11-21

ApplicantOrion Life Systems, Inc.
Decision Date1994-11-21
Product CodeJOL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PRE-FILLED 10CC INFLATION SYRINGE W/STERILE WATER 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 K943836. 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 10CC INFLATION SYRINGE W/STERILE WATER?

PRE-FILLED 10CC INFLATION SYRINGE W/STERILE WATER 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 K943836.

When did PRE-FILLED 10CC INFLATION SYRINGE W/STERILE WATER receive FDA 510(k) clearance?

PRE-FILLED 10CC INFLATION SYRINGE W/STERILE WATER received FDA 510(k) clearance on 1994-11-21, under 510(k) number K943836.

Who is the listed applicant for PRE-FILLED 10CC INFLATION SYRINGE W/STERILE WATER?

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 10CC INFLATION SYRINGE W/STERILE WATER?

The FDA product code for PRE-FILLED 10CC INFLATION SYRINGE W/STERILE WATER is JOL.

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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.

K943835PRE-FILLED SYRINGE W/STERILE .25% ACETC ACIDK943828STERILE WATER FOR IRRIGATIONK943834STERILE .9% SODIUM CHLORIDE SOLUTIONK943831PRE-FILLED 30CC INFLATION SYRINGE W/STERILE WATERK943832STERILE .9% SODIUM CHLORIDE FOR IRRATIONK943830PRE-FILLED SYRINGE W/STERILE 0.9% SODIUM CHLORIDE SOLUTION

View all 33 devices →

Related Devices (Code: JOL)

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.

K051370STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014Baxter Healthcare CorpK000266PRIMARY 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.

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