BERGEN 710 ESU— 510(k) K945861

Substantially Equivalent

Bergen Mfg.

FDA 510(k) clearance K945861 for BERGEN 710 ESU, Substantially Equivalent on 1995-03-01. Applicant: Bergen Mfg.. Device class: 2.

Clearance details

Applicant: Bergen Mfg.
Product code: Code HAM
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 1994-12-01
Decision date: 1995-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Port Richey, FL, US

Download summary PDF View on FDA.gov ↗

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