10-C/SA-10B/U OPT 20-C/20A/U BEAM SA-10B/U HEMORRH— 510(k) K871031

Name: FDA 510(k) clearance K871031
Creator: U.S. Food and Drug Administration
Published: 1987-05-15

Substantially Equivalent

Directed Energy, Inc.

FDA 510(k) clearance K871031 for 10-C/SA-10B/U OPT 20-C/20A/U BEAM SA-10B/U HEMORRH, Substantially Equivalent on 1987-05-15. Applicant: Directed Energy, Inc.. Device class: 2.

Clearance details

Applicant: Directed Energy, Inc.
Product code: Code LNK
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 1987-03-16
Decision date: 1987-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

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