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FDA 510(k)

GERITREX STERILE SALINE SOLUTION FOR IRRIGATION

K-Number: K931509 · 1994-09-22

ApplicantGeritrex Corp.
Decision Date1994-09-22
Product CodeJOL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GERITREX STERILE SALINE SOLUTION FOR IRRIGATION is the device name listed in this FDA 510(k) record. The listed applicant is Geritrex Corp.. It received FDA 510(k) clearance on 1994-09-22 under 510(k) number K931509. 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 GERITREX STERILE SALINE SOLUTION FOR IRRIGATION?

GERITREX STERILE SALINE SOLUTION FOR IRRIGATION is a medical device that received FDA 510(k) clearance on 1994-09-22. The listed applicant is Geritrex Corp.. The 510(k) number is K931509.

When did GERITREX STERILE SALINE SOLUTION FOR IRRIGATION receive FDA 510(k) clearance?

GERITREX STERILE SALINE SOLUTION FOR IRRIGATION received FDA 510(k) clearance on 1994-09-22, under 510(k) number K931509.

Who is the listed applicant for GERITREX STERILE SALINE SOLUTION FOR IRRIGATION?

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

What is the FDA product code for GERITREX STERILE SALINE SOLUTION FOR IRRIGATION?

The FDA product code for GERITREX STERILE SALINE SOLUTION FOR IRRIGATION is JOL.

Related Clinical Trials

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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Other records listing Geritrex Corp. 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.

K945224GRX FOAM DRESSINGK931511GERITREX STERILE WATER FOR IRRIGATIONK931510GERITREX STERILE SALINE WET DRESSING

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

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

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