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FDA 510(k)

COVER UP

K-Number: K881914 · 1988-07-15

ApplicantParkell
Decision Date1988-07-15
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

COVER UP is the device name listed in this FDA 510(k) record. The listed applicant is Parkell. It received FDA 510(k) clearance on 1988-07-15 under 510(k) number K881914. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COVER UP?

COVER UP is a medical device that received FDA 510(k) clearance on 1988-07-15. The listed applicant is Parkell. The 510(k) number is K881914.

When did COVER UP receive FDA 510(k) clearance?

COVER UP received FDA 510(k) clearance on 1988-07-15, under 510(k) number K881914.

Who is the listed applicant for COVER UP?

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

What is the FDA product code for COVER UP?

The FDA product code for COVER UP is EMA.

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Other records listing Parkell 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.

K923867METAFILK905032MOUSSE, POLYVINYL SILOXANE IMPRESSION MATERIALK900303CONNECTK896719PRIMER-P ADHESIVE AGENTK895750HEMA-PRIMERK892003ABRAKADABRA - DENTAL ADHESIVE SYSTEM

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Related Devices (Code: EMA)

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.

K262983EsTemp ImplantSpident Co., Ltd.K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, 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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