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FDA 510(k)

PERMAGEN UNIVERSAL BONDING RESIN

K-Number: K933745 · 1994-01-26

ApplicantBio-Systems Research
Decision Date1994-01-26
Product CodeEBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PERMAGEN UNIVERSAL BONDING RESIN is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Systems Research. It received FDA 510(k) clearance on 1994-01-26 under 510(k) number K933745. The device is classified under product code EBH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERMAGEN UNIVERSAL BONDING RESIN?

PERMAGEN UNIVERSAL BONDING RESIN is a medical device that received FDA 510(k) clearance on 1994-01-26. The listed applicant is Bio-Systems Research. The 510(k) number is K933745.

When did PERMAGEN UNIVERSAL BONDING RESIN receive FDA 510(k) clearance?

PERMAGEN UNIVERSAL BONDING RESIN received FDA 510(k) clearance on 1994-01-26, under 510(k) number K933745.

Who is the listed applicant for PERMAGEN UNIVERSAL BONDING RESIN?

The FDA 510(k) record lists Bio-Systems Research as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PERMAGEN UNIVERSAL BONDING RESIN?

The FDA product code for PERMAGEN UNIVERSAL BONDING RESIN is EBH.

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Other records listing Bio-Systems Research 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.

K962416DRYTIME FOR BLADDER CONTROL SILENT

Related Devices (Code: EBH)

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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