Plancon Microlamellar Keratome (Single Piece Keratome Head with Accessories)

FDA 510(k) K970377 · Plancon Instruments

Substantially Equivalent

510(k) numberK970377

Submission

Device name
Plancon Microlamellar Keratome (Single Piece Keratome Head with Accessories)
Applicant
Plancon Instruments
Antony, FR
Received
February 3, 1997
Decision date
March 31, 1997
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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Questions and answers

When was Plancon Microlamellar Keratome (Single Piece Keratome Head with Accessories) cleared by the FDA?

Plancon Microlamellar Keratome (Single Piece Keratome Head with Accessories) (K970377) received a 510(k) decision of Substantially Equivalent on March 31, 1997, 56 days after the submission was received.

What is the product code of K970377?

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