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FDA 510(k)

CZ-S2000

K-Number: K060946 · 2006-06-15

ApplicantParkell, Inc.
Decision Date2006-06-15
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CZ-S2000 is the device name listed in this FDA 510(k) record. The listed applicant is Parkell, Inc.. It received FDA 510(k) clearance on 2006-06-15 under 510(k) number K060946. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CZ-S2000?

CZ-S2000 is a medical device that received FDA 510(k) clearance on 2006-06-15. The listed applicant is Parkell, Inc.. The 510(k) number is K060946.

When did CZ-S2000 receive FDA 510(k) clearance?

CZ-S2000 received FDA 510(k) clearance on 2006-06-15, under 510(k) number K060946.

Who is the listed applicant for CZ-S2000?

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

What is the FDA product code for CZ-S2000?

The FDA product code for CZ-S2000 is KIF.

Other records listing Parkell, Inc. as applicant

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Related Devices (Code: KIF)

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.

K262050Vioseal XSpident Co., Ltd.K253909NeoPEX™ Pre-Mixed Obturation PasteNuSmile, Ltd.K261514Calcium Hydroxide Temporary Filling Material (KP-Cal)Guilin Kevin Peter Technology Co., Ltd.K261415Injectable Root Canal Sealer (KP-Root SP)Guilin Kevin Peter Technology Co., Ltd.K253167Any-PasteMediclus Co., Ltd.K252890ZenSeal ProKerr Corporation

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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