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FDA 510(k)

AMALGAMIBOND PLUS

K-Number: K960879 · 1996-03-22

ApplicantParkell, Inc.
Decision Date1996-03-22
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AMALGAMIBOND PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Parkell, Inc.. It received FDA 510(k) clearance on 1996-03-22 under 510(k) number K960879. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMALGAMIBOND PLUS?

AMALGAMIBOND PLUS is a medical device that received FDA 510(k) clearance on 1996-03-22. The listed applicant is Parkell, Inc.. The 510(k) number is K960879.

When did AMALGAMIBOND PLUS receive FDA 510(k) clearance?

AMALGAMIBOND PLUS received FDA 510(k) clearance on 1996-03-22, under 510(k) number K960879.

Who is the listed applicant for AMALGAMIBOND PLUS?

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

What is the FDA product code for AMALGAMIBOND PLUS?

The FDA product code for AMALGAMIBOND PLUS is KLE.

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Other records listing Parkell, Inc. as applicant

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Related Devices (Code: KLE)

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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