VAG O SPECULUM, MODELS VS1, VM1, VL1— 510(k) K042950

Name: FDA 510(k) clearance K042950
Creator: U.S. Food and Drug Administration
Published: 2004-11-30

Substantially Equivalent

Panatrex, Inc.

FDA 510(k) clearance K042950 for VAG O SPECULUM, MODELS VS1, VM1, VL1, Substantially Equivalent on 2004-11-30. Applicant: Panatrex, Inc.. Device class: 2.

Clearance details

Applicant: Panatrex, Inc.
Product code: Code HIB
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2004-10-26
Decision date: 2004-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Placentia, CA, US

Download summary PDF View on FDA.gov ↗

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