Benzing Retrograde Admin. Set

FDA 510(k) K823373 · Beech Medical, Inc.

Substantially Equivalent

510(k) numberK823373

Submission

Device name
Benzing Retrograde Admin. Set
Applicant
Beech Medical, Inc.
Walker, MI, US
Received
November 12, 1982
Decision date
December 30, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FMG – Stopcock, I.V. Set
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5440
Specialty
General Hospital

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Questions and answers

When was Benzing Retrograde Admin. Set cleared by the FDA?

Benzing Retrograde Admin. Set (K823373) received a 510(k) decision of Substantially Equivalent on December 30, 1982, 48 days after the submission was received.

What is the product code of K823373?

The FDA product code is FMG – Stopcock, I.V. Set, a Class II (moderate risk) device regulated under 21 CFR 880.5440.