ASMOTOM AUTOMATED TREPHINE SYSTEM— 510(k) K013151

Name: FDA 510(k) clearance K013151
Creator: U.S. Food and Drug Administration
Published: 2001-12-14

Substantially Equivalent

Bkg Opthalmics USA, Inc.

FDA 510(k) clearance K013151 for ASMOTOM AUTOMATED TREPHINE SYSTEM, Substantially Equivalent on 2001-12-14. Applicant: Bkg Opthalmics USA, Inc.. Device class: 1.

Clearance details

Applicant: Bkg Opthalmics USA, Inc.
Product code: Code HRG
Device class: Class 1
Regulation: 21 CFR 886.4070
Advisory panel: Ophthalmic
Date received: 2001-09-20
Decision date: 2001-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Appollo Beach, FL, US

Download summary PDF View on FDA.gov ↗

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