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FDA 510(k)

INTRA-ORAL IRRIGATOR

K-Number: K933547 · 1993-10-20

ApplicantParkell, Inc.
Decision Date1993-10-20
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

INTRA-ORAL IRRIGATOR is the device name listed in this FDA 510(k) record. The listed applicant is Parkell, Inc.. It received FDA 510(k) clearance on 1993-10-20 under 510(k) number K933547. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRA-ORAL IRRIGATOR?

INTRA-ORAL IRRIGATOR is a medical device that received FDA 510(k) clearance on 1993-10-20. The listed applicant is Parkell, Inc.. The 510(k) number is K933547.

When did INTRA-ORAL IRRIGATOR receive FDA 510(k) clearance?

INTRA-ORAL IRRIGATOR received FDA 510(k) clearance on 1993-10-20, under 510(k) number K933547.

Who is the listed applicant for INTRA-ORAL IRRIGATOR?

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 INTRA-ORAL IRRIGATOR?

The FDA product code for INTRA-ORAL IRRIGATOR is ELC.

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Other records listing Parkell, Inc. as applicant

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Related Devices (Code: ELC)

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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