PLANCON MICROLAMELLAR KERATOME (SINGLE PIECE KERATOME HEAD WITH ACCESSORIES)— 510(k) K970377

Substantially Equivalent

Plancon Instruments

FDA 510(k) clearance K970377 for PLANCON MICROLAMELLAR KERATOME (SINGLE PIECE KERATOME HEAD WITH ACCESSORIES), Substantially Equivalent on 1997-03-31. Applicant: Plancon Instruments.

Clearance details

Applicant: Plancon Instruments
Product code: Code HNO
Advisory panel: Ophthalmic
Date received: 1997-02-03
Decision date: 1997-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Antony, FR

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Adverse events under product code HNO

product code HNO

Injury: 390
Total: 390

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.