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FDA 510(k)

OPC LOWWEAR PORCELAIN

K-Number: K982377 · 1998-08-18

ApplicantJeneric/Pentron, Inc.
Decision Date1998-08-18
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OPC LOWWEAR PORCELAIN is the device name listed in this FDA 510(k) record. The listed applicant is Jeneric/Pentron, Inc.. It received FDA 510(k) clearance on 1998-08-18 under 510(k) number K982377. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPC LOWWEAR PORCELAIN?

OPC LOWWEAR PORCELAIN is a medical device that received FDA 510(k) clearance on 1998-08-18. The listed applicant is Jeneric/Pentron, Inc.. The 510(k) number is K982377.

When did OPC LOWWEAR PORCELAIN receive FDA 510(k) clearance?

OPC LOWWEAR PORCELAIN received FDA 510(k) clearance on 1998-08-18, under 510(k) number K982377.

Who is the listed applicant for OPC LOWWEAR PORCELAIN?

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

What is the FDA product code for OPC LOWWEAR PORCELAIN?

The FDA product code for OPC LOWWEAR PORCELAIN is EIH.

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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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