ENDOTOME— 510(k) K790645

Substantially Equivalent

Berkeley Bio-Engineering

FDA 510(k) clearance K790645 for ENDOTOME, Substantially Equivalent on 1979-04-23. Applicant: Berkeley Bio-Engineering. Device class: 1.

Clearance details

Applicant: Berkeley Bio-Engineering
Product code: Code HSZ
Device class: Class 1
Regulation: 21 CFR 878.4820
Advisory panel: General, Plastic Surgery
Date received: 1979-03-30
Decision date: 1979-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.