WOODLYN OPERATION MICROSCOPE— 510(k) K931303

Substantially Equivalent

Woodlyn, Inc.

FDA 510(k) clearance K931303 for WOODLYN OPERATION MICROSCOPE, Substantially Equivalent on 1993-06-25. Applicant: Woodlyn, Inc.. Device class: 1.

Clearance details

Applicant
Woodlyn, Inc.
Product code
Code FSO
Device class
Class 1
Regulation
21 CFR 878.4700
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Arlington Heights, IL, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code FSO

product code FSO
Other
1
Total
1

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 →

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