BIOSIL MEDICAL GRADE SILICONE SHEETING— 510(k) K932176

Name: FDA 510(k) clearance K932176
Creator: U.S. Food and Drug Administration
Published: 1993-12-02

Substantially Equivalent

Bioplexus Corp.

FDA 510(k) clearance K932176 for BIOSIL MEDICAL GRADE SILICONE SHEETING, Substantially Equivalent on 1993-12-02. Applicant: Bioplexus Corp.. Device class: 2.

Clearance details

Applicant: Bioplexus Corp.
Product code: Code KHJ
Device class: Class 2
Regulation: 21 CFR 874.3620
Advisory panel: Ear, Nose, Throat
Date received: 1993-05-05
Decision date: 1993-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Las Vegas, NV, US

Download summary PDF View on FDA.gov ↗

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