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FDA 510(k)

ORAL IRRIGATION TIP

K-Number: K844318 · 1984-11-23

ApplicantPro Pulse, Inc.
Decision Date1984-11-23
Product CodeEFS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORAL IRRIGATION TIP is the device name listed in this FDA 510(k) record. The listed applicant is Pro Pulse, Inc.. It received FDA 510(k) clearance on 1984-11-23 under 510(k) number K844318. The device is classified under product code EFS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORAL IRRIGATION TIP?

ORAL IRRIGATION TIP is a medical device that received FDA 510(k) clearance on 1984-11-23. The listed applicant is Pro Pulse, Inc.. The 510(k) number is K844318.

When did ORAL IRRIGATION TIP receive FDA 510(k) clearance?

ORAL IRRIGATION TIP received FDA 510(k) clearance on 1984-11-23, under 510(k) number K844318.

Who is the listed applicant for ORAL IRRIGATION TIP?

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

What is the FDA product code for ORAL IRRIGATION TIP?

The FDA product code for ORAL IRRIGATION TIP is EFS.

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Related Devices (Code: EFS)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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