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FDA 510(k)

MOLINEA INCONTINENT PAD

K-Number: K843404 · 1984-10-19

ApplicantPaul Hartmann Corp.
Decision Date1984-10-19
Product CodeEYQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MOLINEA INCONTINENT PAD is the device name listed in this FDA 510(k) record. The listed applicant is Paul Hartmann Corp.. It received FDA 510(k) clearance on 1984-10-19 under 510(k) number K843404. 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 MOLINEA INCONTINENT PAD?

MOLINEA INCONTINENT PAD is a medical device that received FDA 510(k) clearance on 1984-10-19. The listed applicant is Paul Hartmann Corp.. The 510(k) number is K843404.

When did MOLINEA INCONTINENT PAD receive FDA 510(k) clearance?

MOLINEA INCONTINENT PAD received FDA 510(k) clearance on 1984-10-19, under 510(k) number K843404.

Who is the listed applicant for MOLINEA INCONTINENT PAD?

The FDA 510(k) record lists Paul Hartmann Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MOLINEA INCONTINENT PAD?

The FDA product code for MOLINEA INCONTINENT PAD 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Paul Hartmann Corp. 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.

K843405MOLICAREK843403MOLINEA PANTYK843401RIA PANTY SHIELDSK843402MOLINEA UNDERPADS

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

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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