BATCH #6060 CONDUCTIVE GEL— 510(k) K983964

Name: FDA 510(k) clearance K983964
Creator: U.S. Food and Drug Administration
Published: 1998-12-09

Substantially Equivalent

Skylark Device Co., Ltd.

FDA 510(k) clearance K983964 for BATCH #6060 CONDUCTIVE GEL, Substantially Equivalent on 1998-12-09. Applicant: Skylark Device Co., Ltd.. Device class: 2.

Clearance details

Applicant: Skylark Device Co., Ltd.
Product code: Code GYB
Device class: Class 2
Regulation: 21 CFR 882.1275
Advisory panel: Neurology
Date received: 1998-11-06
Decision date: 1998-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, TW

Download summary PDF View on FDA.gov ↗

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