TOTAL OSSICULAR REPLACEMENT PROSTHESIS (TORP)— 510(k) K972735

Name: FDA 510(k) clearance K972735
Creator: U.S. Food and Drug Administration
Published: 1997-09-05

Substantially Equivalent

Mednet Locator, Inc.

FDA 510(k) clearance K972735 for TOTAL OSSICULAR REPLACEMENT PROSTHESIS (TORP), Substantially Equivalent on 1997-09-05. Applicant: Mednet Locator, Inc.. Device class: 2.

Clearance details

Applicant: Mednet Locator, Inc.
Product code: Code ETA
Device class: Class 2
Regulation: 21 CFR 874.3495
Advisory panel: Ear, Nose, Throat
Date received: 1997-07-22
Decision date: 1997-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

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