SURGICAL CARBON DIOXIDE SYS. MODEL 10-C OB-GYN USE— 510(k) K862861

Name: FDA 510(k) clearance K862861
Creator: U.S. Food and Drug Administration
Published: 1986-10-27

Substantially Equivalent

Directed Energy, Inc.

FDA 510(k) clearance K862861 for SURGICAL CARBON DIOXIDE SYS. MODEL 10-C OB-GYN USE, Substantially Equivalent on 1986-10-27. Applicant: Directed Energy, Inc.. Device class: 2.

Clearance details

Applicant: Directed Energy, Inc.
Product code: Code HHR
Device class: Class 2
Regulation: 21 CFR 884.4550
Advisory panel: Obstetrics/Gynecology
Date received: 1986-07-29
Decision date: 1986-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

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