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FDA 510(k)

TRANQUILITY

K-Number: K843869 · 1984-11-16

ApplicantPrinciple Business Ent.
Decision Date1984-11-16
Product CodeEYQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TRANQUILITY is the device name listed in this FDA 510(k) record. The listed applicant is Principle Business Ent.. It received FDA 510(k) clearance on 1984-11-16 under 510(k) number K843869. The device is classified under product code EYQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRANQUILITY?

TRANQUILITY is a medical device that received FDA 510(k) clearance on 1984-11-16. The listed applicant is Principle Business Ent.. The 510(k) number is K843869.

When did TRANQUILITY receive FDA 510(k) clearance?

TRANQUILITY received FDA 510(k) clearance on 1984-11-16, under 510(k) number K843869.

Who is the listed applicant for TRANQUILITY?

The FDA 510(k) record lists Principle Business Ent. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRANQUILITY?

The FDA product code for TRANQUILITY is EYQ.

Related Clinical Trials

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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Other records listing Principle Business Ent. as applicant

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.

K810918ROLL-A-SETK810544INCONTINENT PAD & BELT

Related Devices (Code: EYQ)

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.

K950784DRISTAR URINARY INCONTINENCE MANAGEMENT SYSTEMAdvanced Bioresearch Assoc.K932310KIT PAK INCONTINENT SKIN CARE KITKit Pak, Inc.K903342DEODORIZING AND SOUND MUFFLING ANAL PADBiological Resistance, Inc.K891686LIB SYSTEM, BABY/ADULT DIAPERIntera Corp.K885185INTERA SHIELD AND INTERA UNDERGARMENTIntera Corp.K883895DRIPRIDE ULTRA INCONTINENT PADWeyerhaeuser Co.

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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