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FDA 510(k)

CODMAN DISPOSABLE BIPOLAR CARD

K-Number: K851487 · 1985-05-03

ApplicantCodman & Shurtleff, Inc.
Decision Date1985-05-03
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CODMAN DISPOSABLE BIPOLAR CARD is the device name listed in this FDA 510(k) record. The listed applicant is Codman & Shurtleff, Inc.. It received FDA 510(k) clearance on 1985-05-03 under 510(k) number K851487. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CODMAN DISPOSABLE BIPOLAR CARD?

CODMAN DISPOSABLE BIPOLAR CARD is a medical device that received FDA 510(k) clearance on 1985-05-03. The listed applicant is Codman & Shurtleff, Inc.. The 510(k) number is K851487.

When did CODMAN DISPOSABLE BIPOLAR CARD receive FDA 510(k) clearance?

CODMAN DISPOSABLE BIPOLAR CARD received FDA 510(k) clearance on 1985-05-03, under 510(k) number K851487.

Who is the listed applicant for CODMAN DISPOSABLE BIPOLAR CARD?

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

What is the FDA product code for CODMAN DISPOSABLE BIPOLAR CARD?

The FDA product code for CODMAN DISPOSABLE BIPOLAR CARD is GEI.

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Related Devices (Code: GEI)

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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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