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FDA 510(k)

SOFT PLATE CUSHION

K-Number: K813190 · 1982-02-05

ApplicantLeonard Russo Co.
Decision Date1982-02-05
Product CodeEHS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SOFT PLATE CUSHION is the device name listed in this FDA 510(k) record. The listed applicant is Leonard Russo Co.. It received FDA 510(k) clearance on 1982-02-05 under 510(k) number K813190. The device is classified under product code EHS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOFT PLATE CUSHION?

SOFT PLATE CUSHION is a medical device that received FDA 510(k) clearance on 1982-02-05. The listed applicant is Leonard Russo Co.. The 510(k) number is K813190.

When did SOFT PLATE CUSHION receive FDA 510(k) clearance?

SOFT PLATE CUSHION received FDA 510(k) clearance on 1982-02-05, under 510(k) number K813190.

Who is the listed applicant for SOFT PLATE CUSHION?

The FDA 510(k) record lists Leonard Russo Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOFT PLATE CUSHION?

The FDA product code for SOFT PLATE CUSHION is EHS.

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Related Devices (Code: EHS)

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.

K971002SMILE WITH CONFIDENCELloyd V. ZiemendorfK770413CUSHIONS, DENTURE ADHESIVE, ALL-DAYCombe, Inc.

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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