TOPOGRAPHIC MODELING SYSTEM— 510(k) K901363

Name: FDA 510(k) clearance K901363
Creator: U.S. Food and Drug Administration
Published: 1990-05-25

Substantially Equivalent

Computed Anatomy, Inc.

FDA 510(k) clearance K901363 for TOPOGRAPHIC MODELING SYSTEM, Substantially Equivalent on 1990-05-25. Applicant: Computed Anatomy, Inc.. Device class: 1.

Clearance details

Applicant: Computed Anatomy, Inc.
Product code: Code HLQ
Device class: Class 1
Regulation: 21 CFR 886.1350
Advisory panel: Ophthalmic
Date received: 1990-03-23
Decision date: 1990-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

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