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FDA 510(k)

SOLSTICE

K-Number: K102621 · 2011-01-28

ApplicantKerr Corporation
Decision Date2011-01-28
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SOLSTICE is the device name listed in this FDA 510(k) record. The listed applicant is Kerr Corporation. It received FDA 510(k) clearance on 2011-01-28 under 510(k) number K102621. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOLSTICE?

SOLSTICE is a medical device that received FDA 510(k) clearance on 2011-01-28. The listed applicant is Kerr Corporation. The 510(k) number is K102621.

When did SOLSTICE receive FDA 510(k) clearance?

SOLSTICE received FDA 510(k) clearance on 2011-01-28, under 510(k) number K102621.

Who is the listed applicant for SOLSTICE?

The FDA 510(k) record lists Kerr Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOLSTICE?

The FDA product code for SOLSTICE is EBZ.

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Related Devices (Code: EBZ)

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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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