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FDA 510(k)

FLUORO-MARK RADIOPAQUE ANATOMICAL MKR.

K-Number: K801637 · 1980-08-27

ApplicantC.R. Bard, Inc.
Decision Date1980-08-27
Product CodeKPK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FLUORO-MARK RADIOPAQUE ANATOMICAL MKR. is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 1980-08-27 under 510(k) number K801637. The device is classified under product code KPK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLUORO-MARK RADIOPAQUE ANATOMICAL MKR.?

FLUORO-MARK RADIOPAQUE ANATOMICAL MKR. is a medical device that received FDA 510(k) clearance on 1980-08-27. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K801637.

When did FLUORO-MARK RADIOPAQUE ANATOMICAL MKR. receive FDA 510(k) clearance?

FLUORO-MARK RADIOPAQUE ANATOMICAL MKR. received FDA 510(k) clearance on 1980-08-27, under 510(k) number K801637.

Who is the listed applicant for FLUORO-MARK RADIOPAQUE ANATOMICAL MKR.?

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

What is the FDA product code for FLUORO-MARK RADIOPAQUE ANATOMICAL MKR.?

The FDA product code for FLUORO-MARK RADIOPAQUE ANATOMICAL MKR. is KPK.

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Related Devices (Code: KPK)

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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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