Ocu-Film Tip Cover

FDA 510(k) K882750 · Oculab, Inc.

Substantially Equivalent

510(k) numberK882750

Submission

Device name
Ocu-Film Tip Cover
Applicant
Oculab, Inc.
Gendale, CA, US
Received
July 5, 1988
Decision date
August 4, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HKY – Tonometer, Manual
Device class
Class II (moderate risk)
Regulation
21 CFR 886.1930
Specialty
Ophthalmic

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Questions and answers

When was Ocu-Film Tip Cover cleared by the FDA?

Ocu-Film Tip Cover (K882750) received a 510(k) decision of Substantially Equivalent on August 4, 1988, 30 days after the submission was received.

What is the product code of K882750?

The FDA product code is HKY – Tonometer, Manual, a Class II (moderate risk) device regulated under 21 CFR 886.1930.