DeviceClearance

K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES— 510(k) K080070

Substantially Equivalent

Grace Medical, Inc.

FDA 510(k) clearance K080070 for K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES, Substantially Equivalent on 2008-04-17. Applicant: Grace Medical, Inc..

Clearance details

Applicant
Grace Medical, Inc.
Product code
Code ETB
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Memphis, TN, US
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