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FDA 510(k)

SYSNPAR PORCELAIN

K-Number: K910303 · 1991-03-08

ApplicantJeneric/Pentron, Inc.
Decision Date1991-03-08
Product CodeELL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SYSNPAR 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 1991-03-08 under 510(k) number K910303. The device is classified under product code ELL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYSNPAR PORCELAIN?

SYSNPAR PORCELAIN is a medical device that received FDA 510(k) clearance on 1991-03-08. The listed applicant is Jeneric/Pentron, Inc.. The 510(k) number is K910303.

When did SYSNPAR PORCELAIN receive FDA 510(k) clearance?

SYSNPAR PORCELAIN received FDA 510(k) clearance on 1991-03-08, under 510(k) number K910303.

Who is the listed applicant for SYSNPAR 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 SYSNPAR PORCELAIN?

The FDA product code for SYSNPAR PORCELAIN is ELL.

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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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