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FDA 510(k)

SWISSPLUS 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,

K-Number: K002188 · 2000-10-30

ApplicantCore-Vent Corp.
Decision Date2000-10-30
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SWISSPLUS 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, 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 2000-10-30 under 510(k) number K002188. 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 SWISSPLUS 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,?

SWISSPLUS 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, is a medical device that received FDA 510(k) clearance on 2000-10-30. The listed applicant is Core-Vent Corp.. The 510(k) number is K002188.

When did SWISSPLUS 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, receive FDA 510(k) clearance?

SWISSPLUS 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, received FDA 510(k) clearance on 2000-10-30, under 510(k) number K002188.

Who is the listed applicant for SWISSPLUS 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,?

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 SWISSPLUS 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,?

The FDA product code for SWISSPLUS 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, is DZE.

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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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