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FDA 510(k)

FIBERLITE, FIBERLITE HS AND FIBERSEAL

K-Number: K884038 · 1988-12-07

ApplicantJeneric/Pentron, Inc.
Decision Date1988-12-07
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FIBERLITE, FIBERLITE HS AND FIBERSEAL 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 1988-12-07 under 510(k) number K884038. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIBERLITE, FIBERLITE HS AND FIBERSEAL?

FIBERLITE, FIBERLITE HS AND FIBERSEAL is a medical device that received FDA 510(k) clearance on 1988-12-07. The listed applicant is Jeneric/Pentron, Inc.. The 510(k) number is K884038.

When did FIBERLITE, FIBERLITE HS AND FIBERSEAL receive FDA 510(k) clearance?

FIBERLITE, FIBERLITE HS AND FIBERSEAL received FDA 510(k) clearance on 1988-12-07, under 510(k) number K884038.

Who is the listed applicant for FIBERLITE, FIBERLITE HS AND FIBERSEAL?

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 FIBERLITE, FIBERLITE HS AND FIBERSEAL?

The FDA product code for FIBERLITE, FIBERLITE HS AND FIBERSEAL is EBF.

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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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