Charles Endocoagulator Accessory for Arc

FDA 510(k) K780851 · Varian Assoc., Inc.

Substantially Equivalent

510(k) numberK780851

Submission

Device name
Charles Endocoagulator Accessory for Arc
Applicant
Varian Assoc., Inc.
Mchenry, IL, US
Received
May 22, 1978
Decision date
June 30, 1978
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HOB – Clamp, Muscle, Ophthalmic
Device class
Class I (low risk)
Regulation
21 CFR 886.4350
Specialty
Ophthalmic

Other 510(k)s with product code HOB

510(k)DeviceApplicantDecision
K840310Category 6 Opthalmic DevicesHOB · Traditional Imm Enterprises , Ltd.03/16/1984SE
K840101Eye Surgery InstrumentHOB · Traditional Truline Instruments, Inc.03/16/1984SE

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Questions and answers

When was Charles Endocoagulator Accessory for Arc cleared by the FDA?

Charles Endocoagulator Accessory for Arc (K780851) received a 510(k) decision of Substantially Equivalent on June 30, 1978, 39 days after the submission was received.

What is the product code of K780851?

The FDA product code is HOB – Clamp, Muscle, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.4350.