DR7700 OPERATING TABLE— 510(k) K864325

Name: FDA 510(k) clearance K864325
Creator: U.S. Food and Drug Administration
Published: 1986-11-19

Substantially Equivalent

Koken Mfg Company, Inc.

FDA 510(k) clearance K864325 for DR7700 OPERATING TABLE, Substantially Equivalent on 1986-11-19. Applicant: Koken Mfg Company, Inc.. Device class: 1.

Clearance details

Applicant: Koken Mfg Company, Inc.
Product code: Code FQO
Device class: Class 1
Regulation: 21 CFR 878.4960
Advisory panel: General, Plastic Surgery
Date received: 1986-11-03
Decision date: 1986-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FQO

product code FQO

Death: 6
Injury: 145
Malfunction: 685
Total: 836

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.