Keratome Blade, Chirom Model Alk 500500; Keratome Blade, S.C.M.D. Model Turokeratome 400400

FDA 510(k) K980508 · Micro Specialties, Inc.

Substantially Equivalent

510(k) numberK980508

Submission

Device name
Keratome Blade, Chirom Model Alk 500500; Keratome Blade, S.C.M.D. Model Turokeratome 400400
Applicant
Micro Specialties, Inc.
Milford, CT, US
Received
February 10, 1998
Decision date
May 1, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HNO – Keratome, Ac-Powered
Device class
Class I (low risk)
Regulation
21 CFR 886.4370
Specialty
Ophthalmic

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More from Biovision AG

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K980510Keratome Blade (135 Micron, Model 300135), (160 Micron, Model 300160), (200 Micron…HNO · Traditional 05/01/1998SE

Questions and answers

When was Keratome Blade, Chirom Model Alk 500500; Keratome Blade, S.C.M.D. Model Turokeratome 400400 cleared by the FDA?

Keratome Blade, Chirom Model Alk 500500; Keratome Blade, S.C.M.D. Model Turokeratome 400400 (K980508) received a 510(k) decision of Substantially Equivalent on May 1, 1998, 80 days after the submission was received.

What is the product code of K980508?

The FDA product code is HNO – Keratome, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 886.4370.