INSULATED SPECULUM W/ SMOKE EVACUATOR OPTION— 510(k) K922154

Name: FDA 510(k) clearance K922154
Creator: U.S. Food and Drug Administration
Published: 1994-04-21

Substantially Equivalent

Olsen Electrosurgical, Inc.

FDA 510(k) clearance K922154 for INSULATED SPECULUM W/ SMOKE EVACUATOR OPTION, Substantially Equivalent on 1994-04-21. Applicant: Olsen Electrosurgical, Inc.. Device class: 2.

Clearance details

Applicant: Olsen Electrosurgical, Inc.
Product code: Code HIB
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 1992-05-07
Decision date: 1994-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA, US

Download summary PDF View on FDA.gov ↗

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