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FDA 510(k)

WIRED MOUTH PROTECTOR (WMP)

K-Number: K131396 · 2013-09-30

ApplicantElba Laboratories, Inc.
Decision Date2013-09-30
Product CodePFL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

WIRED MOUTH PROTECTOR (WMP) is the device name listed in this FDA 510(k) record. The listed applicant is Elba Laboratories, Inc.. It received FDA 510(k) clearance on 2013-09-30 under 510(k) number K131396. The device is classified under product code PFL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WIRED MOUTH PROTECTOR (WMP)?

WIRED MOUTH PROTECTOR (WMP) is a medical device that received FDA 510(k) clearance on 2013-09-30. The listed applicant is Elba Laboratories, Inc.. The 510(k) number is K131396.

When did WIRED MOUTH PROTECTOR (WMP) receive FDA 510(k) clearance?

WIRED MOUTH PROTECTOR (WMP) received FDA 510(k) clearance on 2013-09-30, under 510(k) number K131396.

Who is the listed applicant for WIRED MOUTH PROTECTOR (WMP)?

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

What is the FDA product code for WIRED MOUTH PROTECTOR (WMP)?

The FDA product code for WIRED MOUTH PROTECTOR (WMP) is PFL.

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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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