Illuminated Speculum

FDA 510(k) K801058 · Designs For Vision, Inc.

Substantially Equivalent

510(k) numberK801058

Submission

Device name
Illuminated Speculum
Applicant
Designs For Vision, Inc.
Mchenry, IL, US
Received
May 6, 1980
Decision date
May 28, 1980
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FXF – Speculum, Illuminated
Device class
Class I (low risk)
Regulation
21 CFR 878.1800
Specialty
General, Plastic Surgery

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Questions and answers

When was Illuminated Speculum cleared by the FDA?

Illuminated Speculum (K801058) received a 510(k) decision of Substantially Equivalent on May 28, 1980, 22 days after the submission was received.

What is the product code of K801058?

The FDA product code is FXF – Speculum, Illuminated, a Class I (low risk) device regulated under 21 CFR 878.1800.