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APACERAM OSSICULAR PROSTHESIS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K893134
510(k) Type
Traditional
Applicant
ASAHI OPTICAL CO. C/O ROSATI ASSOCIATES, P.C.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/3/1989
Days to Decision
100 days

APACERAM OSSICULAR PROSTHESIS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K893134
510(k) Type
Traditional
Applicant
ASAHI OPTICAL CO. C/O ROSATI ASSOCIATES, P.C.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/3/1989
Days to Decision
100 days