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FDA 510(k)

SIALO DRAIN

K-Number: K072334 · 2008-07-18

ApplicantSialo Technology, Ltd.
Decision Date2008-07-18
Product CodeOAJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SIALO DRAIN is the device name listed in this FDA 510(k) record. The listed applicant is Sialo Technology, Ltd.. It received FDA 510(k) clearance on 2008-07-18 under 510(k) number K072334. The device is classified under product code OAJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIALO DRAIN?

SIALO DRAIN is a medical device that received FDA 510(k) clearance on 2008-07-18. The listed applicant is Sialo Technology, Ltd.. The 510(k) number is K072334.

When did SIALO DRAIN receive FDA 510(k) clearance?

SIALO DRAIN received FDA 510(k) clearance on 2008-07-18, under 510(k) number K072334.

Who is the listed applicant for SIALO DRAIN?

The FDA 510(k) record lists Sialo Technology, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIALO DRAIN?

The FDA product code for SIALO DRAIN is OAJ.

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Other records listing Sialo Technology, 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.

K093785MODULAR ENDOSCOPEK082735STONE GRASPING BASKET, MODEL PD-T1 2115K072749SIALO BALLOON DILATATION CATHETER

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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