BIPOLAR ELECTROSURGICAL PENCIL— 510(k) K943031

Name: FDA 510(k) clearance K943031
Creator: U.S. Food and Drug Administration
Published: 1994-09-23

Substantially Equivalent

Boston Surgical Products, Inc.

FDA 510(k) clearance K943031 for BIPOLAR ELECTROSURGICAL PENCIL, Substantially Equivalent on 1994-09-23. Applicant: Boston Surgical Products, Inc.. Device class: 2.

Clearance details

Applicant: Boston Surgical Products, Inc.
Product code: Code HQO
Device class: Class 2
Regulation: 21 CFR 886.4115
Advisory panel: Ophthalmic
Date received: 1994-06-27
Decision date: 1994-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kingston, MA, US

Download summary PDF View on FDA.gov ↗

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