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FDA 510(k)

PALAPRESS(R) VARIO RESIN

K-Number: K902115 · 1990-07-27

ApplicantKulzer, Inc.
Decision Date1990-07-27
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PALAPRESS(R) VARIO RESIN is the device name listed in this FDA 510(k) record. The listed applicant is Kulzer, Inc.. It received FDA 510(k) clearance on 1990-07-27 under 510(k) number K902115. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PALAPRESS(R) VARIO RESIN?

PALAPRESS(R) VARIO RESIN is a medical device that received FDA 510(k) clearance on 1990-07-27. The listed applicant is Kulzer, Inc.. The 510(k) number is K902115.

When did PALAPRESS(R) VARIO RESIN receive FDA 510(k) clearance?

PALAPRESS(R) VARIO RESIN received FDA 510(k) clearance on 1990-07-27, under 510(k) number K902115.

Who is the listed applicant for PALAPRESS(R) VARIO RESIN?

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

What is the FDA product code for PALAPRESS(R) VARIO RESIN?

The FDA product code for PALAPRESS(R) VARIO RESIN is EBI.

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Other records listing Kulzer, Inc. as applicant

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Related Devices (Code: EBI)

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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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