Who is the manufacturer of FLUORO-MARK RADIOPAQUE ANATOMICAL MKR.?

C.R. Bard, Inc. filed the 510(k) submission for FLUORO-MARK RADIOPAQUE ANATOMICAL MKR. (K801637).

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

KPK. It is classified under 21 CFR 878.4650 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for FLUORO-MARK RADIOPAQUE ANATOMICAL MKR.?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like FLUORO-MARK RADIOPAQUE ANATOMICAL MKR.?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

FLUORO-MARK RADIOPAQUE ANATOMICAL MKR.

K801637 · C.R. Bard, Inc. · KPK · Aug 27, 1980 · General, Plastic Surgery

Device Facts

Record ID	K801637
Device Name	FLUORO-MARK RADIOPAQUE ANATOMICAL MKR.
Applicant	C.R. Bard, Inc.
Product Code	KPK · General, Plastic Surgery
Decision Date	Aug 27, 1980
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4650
Device Class	Class 2

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