MAMMOCORE BIOPSY TRAY— 510(k) K943653

Name: FDA 510(k) clearance K943653
Creator: U.S. Food and Drug Administration
Published: 1995-01-30

Unknown

Manan Medical Products, Inc.

FDA 510(k) clearance K943653 for MAMMOCORE BIOPSY TRAY, Unknown on 1995-01-30. Applicant: Manan Medical Products, Inc.. Device class: 2.

Clearance details

Applicant: Manan Medical Products, Inc.
Product code: Code FRG
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 1994-07-28
Decision date: 1995-01-30
Decision: Unknown
Clearance type: Traditional
Location: Northbrook, IL, 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.