H20- TETHERED OPTION— 510(k) K992291

Name: FDA 510(k) clearance K992291
Creator: U.S. Food and Drug Administration
Published: 1999-08-06

Substantially Equivalent

Grass-Telefactor Product Group

FDA 510(k) clearance K992291 for H20- TETHERED OPTION, Substantially Equivalent on 1999-08-06. Applicant: Grass-Telefactor Product Group. Device class: 2.

Clearance details

Applicant: Grass-Telefactor Product Group
Product code: Code OLV
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 1999-07-07
Decision date: 1999-08-06
Decision: Substantially Equivalent
Clearance type: Special
Location: West Conshohocken, PA, US

Download summary PDF View on FDA.gov ↗

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