FDA 510(k)

SHARPSOLOGY 2

K-Number: K133031 · 2013-11-15

ApplicantIndustrial Water Solutions, Inc.

Decision Date2013-11-15

Product CodeMMK

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SHARPSOLOGY 2 is the device name listed in this FDA 510(k) record. The listed applicant is Industrial Water Solutions, Inc.. It received FDA 510(k) clearance on 2013-11-15 under 510(k) number K133031. The device is classified under product code MMK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHARPSOLOGY 2?

SHARPSOLOGY 2 is a medical device that received FDA 510(k) clearance on 2013-11-15. The listed applicant is Industrial Water Solutions, Inc.. The 510(k) number is K133031.

When did SHARPSOLOGY 2 receive FDA 510(k) clearance?

SHARPSOLOGY 2 received FDA 510(k) clearance on 2013-11-15, under 510(k) number K133031.

Who is the listed applicant for SHARPSOLOGY 2?

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

What is the FDA product code for SHARPSOLOGY 2?

The FDA product code for SHARPSOLOGY 2 is MMK.

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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.