Phacopak

FDA 510(k) K974719 · Paradigm Medical Industries, Inc.

Substantially Equivalent

510(k) numberK974719

Submission

Device name
Phacopak
Applicant
Paradigm Medical Industries, Inc.
Salt Lake City, UT, US
Received
December 18, 1997
Decision date
January 20, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
HQC – Unit, Phacofragmentation
Device class
Class II (moderate risk)
Regulation
21 CFR 886.4670
Specialty
Ophthalmic

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Questions and answers

When was Phacopak cleared by the FDA?

Phacopak (K974719) received a 510(k) decision of Substantially Equivalent on January 20, 1998, 33 days after the submission was received.

What is the product code of K974719?

The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.