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FDA 510(k)

SWEDE-VENT IMPLANT

K-Number: K950577 · 1995-07-11

ApplicantCore-Vent Corp.
Decision Date1995-07-11
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SWEDE-VENT IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Core-Vent Corp.. It received FDA 510(k) clearance on 1995-07-11 under 510(k) number K950577. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SWEDE-VENT IMPLANT?

SWEDE-VENT IMPLANT is a medical device that received FDA 510(k) clearance on 1995-07-11. The listed applicant is Core-Vent Corp.. The 510(k) number is K950577.

When did SWEDE-VENT IMPLANT receive FDA 510(k) clearance?

SWEDE-VENT IMPLANT received FDA 510(k) clearance on 1995-07-11, under 510(k) number K950577.

Who is the listed applicant for SWEDE-VENT IMPLANT?

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

What is the FDA product code for SWEDE-VENT IMPLANT?

The FDA product code for SWEDE-VENT IMPLANT is DZE.

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Other records listing Core-Vent Corp. 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.

K002614ADVENT IMPLANT SYSTEMK002188SWISSPLUS IMPLANT SYSTEM, MODEL SPWB 8,10,12,14/OPH20/SMPR, SPB 8,10,12,14/OP3.5D/OPAR,OPB 8,10,12,14/OP2.3D/OP2.8D,K950579MICRO-VENT IMPLANTK950575BIO-VENT IMPLANTK950578SCREW-VENT IMPLANTK950576BIO-VENT X IMPLANT

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Related Devices (Code: DZE)

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.

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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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