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FDA 510(k)

BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500

K-Number: K062438 · 2006-10-27

ApplicantCook Ob/Gyn
Decision Date2006-10-27
Product CodeKNA
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500 is the device name listed in this FDA 510(k) record. The listed applicant is Cook Ob/Gyn. It received FDA 510(k) clearance on 2006-10-27 under 510(k) number K062438. 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 BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500?

BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500 is a medical device that received FDA 510(k) clearance on 2006-10-27. The listed applicant is Cook Ob/Gyn. The 510(k) number is K062438.

When did BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500 receive FDA 510(k) clearance?

BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500 received FDA 510(k) clearance on 2006-10-27, under 510(k) number K062438.

Who is the listed applicant for BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500?

The FDA 510(k) record lists Cook Ob/Gyn as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500?

The FDA product code for BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500 is KNA.

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Other records listing Cook Ob/Gyn 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.

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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.K060289EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01Frontline MedicalK013597TAMPONADE UTERINE BALLOON CATHETER SETCook Ob/GynK014248DND 202 MANUAL UROLOGICAL DIGITAL NEEDLE DRIVERUrogyn , Ltd.

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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