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FDA 510(k)

MENTOR EVACARE VAGINAL PESSARIES

K-Number: K993308 · 1999-12-13

ApplicantMentor Corp.
Decision Date1999-12-13
Product CodeHHW
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MENTOR EVACARE VAGINAL PESSARIES is the device name listed in this FDA 510(k) record. The listed applicant is Mentor Corp.. It received FDA 510(k) clearance on 1999-12-13 under 510(k) number K993308. 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 MENTOR EVACARE VAGINAL PESSARIES?

MENTOR EVACARE VAGINAL PESSARIES is a medical device that received FDA 510(k) clearance on 1999-12-13. The listed applicant is Mentor Corp.. The 510(k) number is K993308.

When did MENTOR EVACARE VAGINAL PESSARIES receive FDA 510(k) clearance?

MENTOR EVACARE VAGINAL PESSARIES received FDA 510(k) clearance on 1999-12-13, under 510(k) number K993308.

Who is the listed applicant for MENTOR EVACARE VAGINAL PESSARIES?

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

What is the FDA product code for MENTOR EVACARE VAGINAL PESSARIES?

The FDA product code for MENTOR EVACARE VAGINAL PESSARIES is HHW.

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Other records listing Mentor 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.

K130813MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERSK053414MENTOR NOVASILK MESHK050008MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETERK042851MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KITK040959MENTOR GENESIS PENILE PROSTHESISK031767MENTOR OBTAPE TRANS-OBTURATOR TAPE

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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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