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FDA 510(k)

IRRIGATION SYRINGE KIT

K-Number: K982435 · 1998-11-06

ApplicantSub-Q, Inc.
Decision Date1998-11-06
Product CodeKYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

IRRIGATION SYRINGE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Sub-Q, Inc.. It received FDA 510(k) clearance on 1998-11-06 under 510(k) number K982435. The device is classified under product code KYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRRIGATION SYRINGE KIT?

IRRIGATION SYRINGE KIT is a medical device that received FDA 510(k) clearance on 1998-11-06. The listed applicant is Sub-Q, Inc.. The 510(k) number is K982435.

When did IRRIGATION SYRINGE KIT receive FDA 510(k) clearance?

IRRIGATION SYRINGE KIT received FDA 510(k) clearance on 1998-11-06, under 510(k) number K982435.

Who is the listed applicant for IRRIGATION SYRINGE KIT?

The FDA 510(k) record lists Sub-Q, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IRRIGATION SYRINGE KIT?

The FDA product code for IRRIGATION SYRINGE KIT is KYZ.

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 Sub-Q, 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.

K991254QS DELIVERY SYSTEM

Related Devices (Code: KYZ)

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.

K201877OtoSet- Ear Cleaning SystemSafkan, Inc.K102563SINGLE CANNULA EXTENDED APPLICATORMicromedics, Inc.K092022TISSU TRANS HARVEST TUBINGShippert Medical Technologies Corp.K050797TISSU-TRANSShippert Medical Technologies Corp.K991254QS DELIVERY SYSTEMSub-Q, Inc.K974288ZEROWET SPLASHIELDZerowet, Inc.

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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