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FDA 510(k)

PANPAC VAGINAL DILATORS

K-Number: K130273 · 2013-08-08

ApplicantPanpac Medical Corporation
Decision Date2013-08-08
Product CodeHDX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

PANPAC VAGINAL DILATORS 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 2013-08-08 under 510(k) number K130273. The device is classified under product code HDX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PANPAC VAGINAL DILATORS?

PANPAC VAGINAL DILATORS is a medical device that received FDA 510(k) clearance on 2013-08-08. The listed applicant is Panpac Medical Corporation. The 510(k) number is K130273.

When did PANPAC VAGINAL DILATORS receive FDA 510(k) clearance?

PANPAC VAGINAL DILATORS received FDA 510(k) clearance on 2013-08-08, under 510(k) number K130273.

Who is the listed applicant for PANPAC VAGINAL DILATORS?

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 VAGINAL DILATORS?

The FDA product code for PANPAC VAGINAL DILATORS is HDX.

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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 CURETTESK153422Panpac Disposable Pessary Fitting SetK102898BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA SONOHYSTEROGRAPHY CATHETER WITHOUT CERVICAL CONEK092982THE PANPAC SUCTION CURETTEK092981PANPAC VAGINAL PESSARY

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Related Devices (Code: HDX)

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.

K241748Intimate Rose Vaginal DilatorsPlus EV Holdings Dba Intimate RoseK233689Hope&Her Vaginal DilatorsLujena, Inc.K222492Hope&Her Vaginal DilatorsLujena, Inc.K231430Intimate Rose Vaginal DilatorsPlus EV Holdings Dba Intimate RoseK220035Milli Vaginal DilatorMaterna MedicalK211959Milli Vaginal DilatorMaterna Medical

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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