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FDA 510(k)

PRIMARY CARE SOLUTIONS, INC., STERILE WATER AND SALINE FOR IRRIGATION

K-Number: K082330 · 2008-10-09

ApplicantPrimary Care Solutions, Inc.
Decision Date2008-10-09
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

PRIMARY CARE SOLUTIONS, INC., STERILE WATER AND SALINE FOR 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 2008-10-09 under 510(k) number K082330. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRIMARY CARE SOLUTIONS, INC., STERILE WATER AND SALINE FOR IRRIGATION?

PRIMARY CARE SOLUTIONS, INC., STERILE WATER AND SALINE FOR IRRIGATION is a medical device that received FDA 510(k) clearance on 2008-10-09. The listed applicant is Primary Care Solutions, Inc.. The 510(k) number is K082330.

When did PRIMARY CARE SOLUTIONS, INC., STERILE WATER AND SALINE FOR IRRIGATION receive FDA 510(k) clearance?

PRIMARY CARE SOLUTIONS, INC., STERILE WATER AND SALINE FOR IRRIGATION received FDA 510(k) clearance on 2008-10-09, under 510(k) number K082330.

Who is the listed applicant for PRIMARY CARE SOLUTIONS, INC., STERILE WATER AND SALINE FOR 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, INC., STERILE WATER AND SALINE FOR IRRIGATION?

The FDA product code for PRIMARY CARE SOLUTIONS, INC., STERILE WATER AND SALINE FOR IRRIGATION is FRO. This falls under the Anesthesiology category.

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.

K030813PRIMARY 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 IRRIGATIONK000265PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION

Related Devices (Code: FRO)

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.

K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbHK254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLCK261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.

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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