Cavidry

FDA 510(k) K822896 · Parker Laboratories, Inc.

Substantially Equivalent

510(k) numberK822896

Submission

Device name
Cavidry
Applicant
Parker Laboratories, Inc.
Mchenry, IL, US
Received
September 29, 1982
Decision date
October 22, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
EJH – Alloy, Metal, Base
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3710
Specialty
Dental

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Questions and answers

When was Cavidry cleared by the FDA?

Cavidry (K822896) received a 510(k) decision of Substantially Equivalent on October 22, 1982, 23 days after the submission was received.

What is the product code of K822896?

The FDA product code is EJH – Alloy, Metal, Base, a Class II (moderate risk) device regulated under 21 CFR 872.3710.