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FDA 510(k)

EPIC-FLO

K-Number: K973976 · 1997-12-04

ApplicantParkell, Inc.
Decision Date1997-12-04
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EPIC-FLO is the device name listed in this FDA 510(k) record. The listed applicant is Parkell, Inc.. It received FDA 510(k) clearance on 1997-12-04 under 510(k) number K973976. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPIC-FLO?

EPIC-FLO is a medical device that received FDA 510(k) clearance on 1997-12-04. The listed applicant is Parkell, Inc.. The 510(k) number is K973976.

When did EPIC-FLO receive FDA 510(k) clearance?

EPIC-FLO received FDA 510(k) clearance on 1997-12-04, under 510(k) number K973976.

Who is the listed applicant for EPIC-FLO?

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 EPIC-FLO?

The FDA product code for EPIC-FLO is EBF.

Other records listing Parkell, Inc. as applicant

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Related Devices (Code: EBF)

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.

K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC America, 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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