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FDA 510(k)

ROWDEN UTERINE MANIPULATOR INJECTOR AND RUMI

K-Number: K932115 · 1994-06-24

ApplicantBlairden Precision Instruments, Inc.
Decision Date1994-06-24
Product CodeLKF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ROWDEN UTERINE MANIPULATOR INJECTOR AND RUMI is the device name listed in this FDA 510(k) record. The listed applicant is Blairden Precision Instruments, Inc.. It received FDA 510(k) clearance on 1994-06-24 under 510(k) number K932115. The device is classified under product code LKF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROWDEN UTERINE MANIPULATOR INJECTOR AND RUMI?

ROWDEN UTERINE MANIPULATOR INJECTOR AND RUMI is a medical device that received FDA 510(k) clearance on 1994-06-24. The listed applicant is Blairden Precision Instruments, Inc.. The 510(k) number is K932115.

When did ROWDEN UTERINE MANIPULATOR INJECTOR AND RUMI receive FDA 510(k) clearance?

ROWDEN UTERINE MANIPULATOR INJECTOR AND RUMI received FDA 510(k) clearance on 1994-06-24, under 510(k) number K932115.

Who is the listed applicant for ROWDEN UTERINE MANIPULATOR INJECTOR AND RUMI?

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

What is the FDA product code for ROWDEN UTERINE MANIPULATOR INJECTOR AND RUMI?

The FDA product code for ROWDEN UTERINE MANIPULATOR INJECTOR AND RUMI is LKF.

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Other records listing Blairden Precision Instruments, Inc. 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.

K912761SURGICAL SAW BLADES

Related Devices (Code: LKF)

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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Official Source

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