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FDA 510(k)

TWIN BALLOON INJECTOR

K-Number: K902975 · 1990-09-26

ApplicantZinnanti Surgical Instruments, Inc.
Decision Date1990-09-26
Product CodeLKF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

TWIN BALLOON INJECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Zinnanti Surgical Instruments, Inc.. It received FDA 510(k) clearance on 1990-09-26 under 510(k) number K902975. 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 TWIN BALLOON INJECTOR?

TWIN BALLOON INJECTOR is a medical device that received FDA 510(k) clearance on 1990-09-26. The listed applicant is Zinnanti Surgical Instruments, Inc.. The 510(k) number is K902975.

When did TWIN BALLOON INJECTOR receive FDA 510(k) clearance?

TWIN BALLOON INJECTOR received FDA 510(k) clearance on 1990-09-26, under 510(k) number K902975.

Who is the listed applicant for TWIN BALLOON INJECTOR?

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

What is the FDA product code for TWIN BALLOON INJECTOR?

The FDA product code for TWIN BALLOON INJECTOR is LKF.

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Other records listing Zinnanti Surgical Instruments, Inc. as applicant

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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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