CYGNUS INSTRUMENT PROTECTORS— 510(k) K964256

Name: FDA 510(k) clearance K964256
Creator: U.S. Food and Drug Administration
Published: 1997-05-06

Substantially Equivalent

Madison Polymeric Engineering

FDA 510(k) clearance K964256 for CYGNUS INSTRUMENT PROTECTORS, Substantially Equivalent on 1997-05-06. Applicant: Madison Polymeric Engineering. Device class: 2.

Clearance details

Applicant: Madison Polymeric Engineering
Product code: Code FRG
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 1996-10-25
Decision date: 1997-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wallingford, CT, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FRG

product code FRG

Other: 3
Total: 3

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.