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FDA 510(k)

CONNECT

K-Number: K900303 · 1990-04-12

ApplicantParkell
Decision Date1990-04-12
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CONNECT is the device name listed in this FDA 510(k) record. The listed applicant is Parkell. It received FDA 510(k) clearance on 1990-04-12 under 510(k) number K900303. 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 CONNECT?

CONNECT is a medical device that received FDA 510(k) clearance on 1990-04-12. The listed applicant is Parkell. The 510(k) number is K900303.

When did CONNECT receive FDA 510(k) clearance?

CONNECT received FDA 510(k) clearance on 1990-04-12, under 510(k) number K900303.

Who is the listed applicant for CONNECT?

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 CONNECT?

The FDA product code for CONNECT is EMA.

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Related PubMed Literature

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.

PMID: 36258781The Complex Process of Using the Interconnected Knee Arthroplasty Device Clearance Pathway.HSS journal : the musculoskeletal journal of Hospital for Special Surgery ()PMID: 34161960The Interconnected Ancestral Network of Hip Arthroplasty Device Approval.The Journal of the American Academy of Orthopaedic Surgeons ()

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 MATERIALK896719PRIMER-P ADHESIVE AGENTK895750HEMA-PRIMERK892003ABRAKADABRA - DENTAL ADHESIVE SYSTEMK884918PORCELAIN ETCHING GEL AND ETCHING GEL BARRIER

View all 8 devices →

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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