MPORT FOLDABLE LENS PLACEMENT SYSTEM— 510(k) K970727

Substantially Equivalent

Chiron Vision Corp.

FDA 510(k) clearance K970727 for MPORT FOLDABLE LENS PLACEMENT SYSTEM, Substantially Equivalent on 1997-12-17. Applicant: Chiron Vision Corp.. Device class: 1.

Clearance details

Applicant
Chiron Vision Corp.
Product code
Code MSS
Device class
Class 1
Regulation
21 CFR 886.4300
Advisory panel
Ophthalmic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Claremont, CA, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code MSS

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More clearances from Chiron Vision Corp.

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Adverse events under product code MSS

product code MSS
Injury
385
Malfunction
2,033
Total
2,418

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

Recalls naming K970727

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K970727.

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