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FDA 510(k)

WORD BARTHOLIN GLAND CATHETER CODE: 1005

K-Number: K880497 · 1988-03-24

ApplicantHoosier Specialties, Inc.
Decision Date1988-03-24
Product CodeKNA
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

WORD BARTHOLIN GLAND CATHETER CODE: 1005 is the device name listed in this FDA 510(k) record. The listed applicant is Hoosier Specialties, Inc.. It received FDA 510(k) clearance on 1988-03-24 under 510(k) number K880497. The device is classified under product code KNA. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WORD BARTHOLIN GLAND CATHETER CODE: 1005?

WORD BARTHOLIN GLAND CATHETER CODE: 1005 is a medical device that received FDA 510(k) clearance on 1988-03-24. The listed applicant is Hoosier Specialties, Inc.. The 510(k) number is K880497.

When did WORD BARTHOLIN GLAND CATHETER CODE: 1005 receive FDA 510(k) clearance?

WORD BARTHOLIN GLAND CATHETER CODE: 1005 received FDA 510(k) clearance on 1988-03-24, under 510(k) number K880497.

Who is the listed applicant for WORD BARTHOLIN GLAND CATHETER CODE: 1005?

The FDA 510(k) record lists Hoosier Specialties, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WORD BARTHOLIN GLAND CATHETER CODE: 1005?

The FDA product code for WORD BARTHOLIN GLAND CATHETER CODE: 1005 is KNA.

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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Related Devices (Code: KNA)

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.

K102141COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)Cook Urological, Inc.K093904GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETERGlenveigh Surgical, LLCK082939COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400Cook Urological, Inc.K062438BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500Cook Ob/GynK060289EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01Frontline MedicalK013597TAMPONADE UTERINE BALLOON CATHETER SETCook Ob/Gyn

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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