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FDA 510(k)

CONTEX

K-Number: K790995 · 1979-06-11

ApplicantFoam Tek, Inc.
Decision Date1979-06-11
Product CodeFMP
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CONTEX is the device name listed in this FDA 510(k) record. The listed applicant is Foam Tek, Inc.. It received FDA 510(k) clearance on 1979-06-11 under 510(k) number K790995. The device is classified under product code FMP. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONTEX?

CONTEX is a medical device that received FDA 510(k) clearance on 1979-06-11. The listed applicant is Foam Tek, Inc.. The 510(k) number is K790995.

When did CONTEX receive FDA 510(k) clearance?

CONTEX received FDA 510(k) clearance on 1979-06-11, under 510(k) number K790995.

Who is the listed applicant for CONTEX?

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

What is the FDA product code for CONTEX?

The FDA product code for CONTEX is FMP.

Related Clinical Trials

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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: 42745015Lean-Agile Product Development in FDA Relevant and Regulated Medical Device Contexts.Therapeutic innovation & regulatory science ()PMID: 42222899Interpreting the two-hour partial REBOA safety window: Physiologic context, monitoring limitations, and device-specific considerations.The journal of trauma and acute care surgery ()PMID: 34161248Possible Contexts of Use for In Silico Trials Methodologies: A Consensus-Based Review.IEEE journal of biomedical and health informatics ()PMID: 31169870Evaluating New Ophthalmic Digital Devices for Safety and Effectiveness in the Context of Rapid Technological Development.JAMA ophthalmology ()

Related Devices (Code: FMP)

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.

K951325COMFEEL PLUS PRESSURE RELIEF DRESSINGRichard Hamer Assoc., Inc.K934731MEDSURG STERILE IMAGING PRODUCTSMedsurg Industries, Inc.K820584DECUBICARE PADS & ACCESSORIESAbco Dealers, Inc.K812344HEEL OR ELBOW PROTECTORFred Sammons, Inc.K811184SPENCO DERMAL PADSSpenco Medical Corp.K802829SCANLAN VASCU-STATTScanlan Intl., Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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