Modification of Anterior Segment Electrodes

FDA 510(k) K933527 · Mira, Inc.

Substantially Equivalent

510(k) numberK933527

Submission

Device name
Modification of Anterior Segment Electrodes
Applicant
Mira, Inc.
Waltham, MA, US
Received
July 20, 1993
Decision date
January 25, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
HWA – Impactor
Device class
Class I (low risk)
Regulation
21 CFR 888.4540
Specialty
Orthopedic

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Questions and answers

When was Modification of Anterior Segment Electrodes cleared by the FDA?

Modification of Anterior Segment Electrodes (K933527) received a 510(k) decision of Substantially Equivalent on January 25, 1994, 189 days after the submission was received.

What is the product code of K933527?

The FDA product code is HWA – Impactor, a Class I (low risk) device regulated under 21 CFR 888.4540.