Pallikaris Brush

FDA 510(k) K960261 · Alcon Laboratories, Inc.

Substantially Equivalent

510(k) numberK960261

Submission

Device name
Pallikaris Brush
Applicant
Alcon Laboratories, Inc.
Orlando, FL, US
Received
January 18, 1996
Decision date
March 11, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
HOG – Burr, Corneal, Battery-Powered
Device class
Class I (low risk)
Regulation
21 CFR 886.4070
Specialty
Ophthalmic

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K883785Gy-Ro SafeHOG · Traditional Gy-Ro Industry, Inc.01/05/1989SE
K834354Ophtec Rust Ring RemoverHOG · Traditional Jedmed Instrument Co.03/19/1984SE

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Questions and answers

When was Pallikaris Brush cleared by the FDA?

Pallikaris Brush (K960261) received a 510(k) decision of Substantially Equivalent on March 11, 1996, 53 days after the submission was received.

What is the product code of K960261?

The FDA product code is HOG – Burr, Corneal, Battery-Powered, a Class I (low risk) device regulated under 21 CFR 886.4070.