Flat Suction Drain

FDA 510(k) K830610 · Sil-Med Corp.

Substantially Equivalent

510(k) numberK830610

Submission

Device name
Flat Suction Drain
Applicant
Sil-Med Corp.
Mchenry, IL, US
Received
February 25, 1983
Decision date
March 29, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GBC – Lamp, Surgical, Incandescent
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4580
Specialty
General, Plastic Surgery

Other 510(k)s with product code GBC

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K896961Halux Exlite Minor Surgery LightGBC · Traditional Jedmed Instrument Co.02/22/1990SE
K811311Skytron Elite Surgical TablesGBC · Traditional Skytron, Div. the Kmw Group, Inc.06/02/1981SE
K810207Minor Surgery LightGBC · Traditional Cavitron Corp.02/13/1981SE

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Questions and answers

When was Flat Suction Drain cleared by the FDA?

Flat Suction Drain (K830610) received a 510(k) decision of Substantially Equivalent on March 29, 1983, 32 days after the submission was received.

What is the product code of K830610?

The FDA product code is GBC – Lamp, Surgical, Incandescent, a Class II (moderate risk) device regulated under 21 CFR 878.4580.