APACERAM OSSICULAR PROSTHESIS— 510(k) K893134

Substantially Equivalent

Asahi Optical Co. C/O Rosati Associates, P.C.

FDA 510(k) clearance K893134 for APACERAM OSSICULAR PROSTHESIS, Substantially Equivalent on 1989-08-03. Applicant: Asahi Optical Co. C/O Rosati Associates, P.C..

Clearance details

Applicant: Asahi Optical Co. C/O Rosati Associates, P.C.
Product code: Code ETB
Advisory panel: Ear, Nose, Throat
Date received: 1989-04-25
Decision date: 1989-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Birmingham, MI, US

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