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FDA 510(k)

Panpac Disposable Pessary Fitting Set

K-Number: K153422 · 2016-07-14

ApplicantPanpac Medical Corporation
Decision Date2016-07-14
Product CodeHHW
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Panpac Disposable Pessary Fitting Set is the device name listed in this FDA 510(k) record. The listed applicant is Panpac Medical Corporation. It received FDA 510(k) clearance on 2016-07-14 under 510(k) number K153422. The device is classified under product code HHW. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Panpac Disposable Pessary Fitting Set?

Panpac Disposable Pessary Fitting Set is a medical device that received FDA 510(k) clearance on 2016-07-14. The listed applicant is Panpac Medical Corporation. The 510(k) number is K153422.

When did Panpac Disposable Pessary Fitting Set receive FDA 510(k) clearance?

Panpac Disposable Pessary Fitting Set received FDA 510(k) clearance on 2016-07-14, under 510(k) number K153422.

Who is the listed applicant for Panpac Disposable Pessary Fitting Set?

The FDA 510(k) record lists Panpac Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Panpac Disposable Pessary Fitting Set?

The FDA product code for Panpac Disposable Pessary Fitting Set is HHW.

Other records listing Panpac Medical Corporation 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.

K173351Panpac Flexi Shelf PessaryK161106PANPAC DISPOSABLE VACUUM CURETTES

Related Devices (Code: HHW)

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.

K253698Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage HolesCooper SurgicalK250438CooperSurgical Milex® PessariesCooperSurgical, Inc.K240798Cntrl+ Bladder Support PessaryCntrl+, Inc.K232677Reia pessaryReia, LLCK232525Yoni.Fit Bladder SupportWatkins-Conti Products, Inc.K233548Uresta®Resilia, Inc.

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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