NUGARD, SENSIFLEX PROCEDURE EXAMINATION GLOVES— 510(k) K083337

Substantially Equivalent

Terang Nusa Sdn Bhd

FDA 510(k) clearance K083337 for NUGARD, SENSIFLEX PROCEDURE EXAMINATION GLOVES, Substantially Equivalent on 2009-01-27. Applicant: Terang Nusa Sdn Bhd.

Clearance details

Applicant: Terang Nusa Sdn Bhd
Product code: Code LYY
Advisory panel: General Hospital
Date received: 2008-11-12
Decision date: 2009-01-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Kota Bharu, Kelantan, MY

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