BG PATIENT EXAMINATION GLOVES, NON-STERILE— 510(k) K961675

Substantially Equivalent

Biografik (Malaysia) Sdn Bhd

FDA 510(k) clearance K961675 for BG PATIENT EXAMINATION GLOVES, NON-STERILE, Substantially Equivalent on 1996-07-25. Applicant: Biografik (Malaysia) Sdn Bhd. Device class: 1.

Clearance details

Applicant
Biografik (Malaysia) Sdn Bhd
Product code
Code LYY
Device class
Class 1
Regulation
21 CFR 880.6250
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Nilai, Negeri Sembilan, MY
Download summary PDFView on FDA.gov ↗

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