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FDA 510(k)

DISPOSABLE SUCTION AND IRRIGATION SYSTEM

K-Number: K093479 · 2010-05-19

ApplicantModern Medical Equipment Mfg., Ltd.
Decision Date2010-05-19
Product CodeFHF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE SUCTION AND IRRIGATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Modern Medical Equipment Mfg., Ltd.. It received FDA 510(k) clearance on 2010-05-19 under 510(k) number K093479. The device is classified under product code FHF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE SUCTION AND IRRIGATION SYSTEM?

DISPOSABLE SUCTION AND IRRIGATION SYSTEM is a medical device that received FDA 510(k) clearance on 2010-05-19. The listed applicant is Modern Medical Equipment Mfg., Ltd.. The 510(k) number is K093479.

When did DISPOSABLE SUCTION AND IRRIGATION SYSTEM receive FDA 510(k) clearance?

DISPOSABLE SUCTION AND IRRIGATION SYSTEM received FDA 510(k) clearance on 2010-05-19, under 510(k) number K093479.

Who is the listed applicant for DISPOSABLE SUCTION AND IRRIGATION SYSTEM?

The FDA 510(k) record lists Modern Medical Equipment Mfg., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISPOSABLE SUCTION AND IRRIGATION SYSTEM?

The FDA product code for DISPOSABLE SUCTION AND IRRIGATION SYSTEM is FHF.

Related Clinical Trials

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Other records listing Modern Medical Equipment Mfg., Ltd. 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.

K091511MODERN MEDICAL RESECTOSCOPE ELECTRODESK070812DISPOSABLE LAPAROSCOPIC INSTRUMENTK070877ENDOCERVICAL ELECTRODE # 2K050842AGCEL WOUND DRESSING,AGCEL BURN DRESSINGK043036NON-STICK ELECTRODEK033095SMOKE EVACUATION ATTACHEMENT

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Related Devices (Code: FHF)

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.

K003443SUCTION IRRIGATORApplied MedicalK771986CATHETER, MEDIASTINAL&PERICARDIALThe Minnesota Back Brace Co.

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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