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FDA 510(k)

PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION

K-Number: K000265 · 2001-07-12

ApplicantPrimary Care Solutions, Inc.
Decision Date2001-07-12
Product CodeJOL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION is the device name listed in this FDA 510(k) record. The listed applicant is Primary Care Solutions, Inc.. It received FDA 510(k) clearance on 2001-07-12 under 510(k) number K000265. 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 PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION?

PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION is a medical device that received FDA 510(k) clearance on 2001-07-12. The listed applicant is Primary Care Solutions, Inc.. The 510(k) number is K000265.

When did PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION receive FDA 510(k) clearance?

PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION received FDA 510(k) clearance on 2001-07-12, under 510(k) number K000265.

Who is the listed applicant for PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION?

The FDA 510(k) record lists Primary Care Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION?

The FDA product code for PRIMARY CARE SOLUTIONS STERILE WATER DEVICE 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 Primary Care Solutions, 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.

K082330PRIMARY CARE SOLUTIONS, INC., STERILE WATER AND SALINE FOR IRRIGATIONK030813PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE WATER CATALOG NUMBERS 1010 ANDK000266PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION

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.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 LaboratoriesK974759HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 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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