VOCOM (VOCAL CORD MEDIALIZATION) IMPLANT— 510(k) K974311

Substantially Equivalent

Gyrus Ent LLC

FDA 510(k) clearance K974311 for VOCOM (VOCAL CORD MEDIALIZATION) IMPLANT, Substantially Equivalent on 1998-03-04. Applicant: Gyrus Ent LLC.

Clearance details

Applicant: Gyrus Ent LLC
Product code: Code KHJ
Advisory panel: Ear, Nose, Throat
Date received: 1997-11-17
Decision date: 1998-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bartlett, TN, US

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