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510(k) K893134

APACERAM OSSICULAR PROSTHESIS by Asahi Optical Co. C/O Rosati Associates, P.C. — Product Code ETB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1989
Date Received
April 25, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Partial Ossicular Replacement
Device Class
Class II
Regulation Number
874.3450
Review Panel
EN
Submission Type

Other clearances by Asahi Optical Co. C/O Rosati Associates, P.C.

  • K885133 — APACERAM ARTIFICIAL DENTAL IMPLANT (September 5, 1989)
  • K872089 — APACERAM HYDROXYLAPATITE DENTAL IMPLANT (TYPE G) (August 14, 1987)
  • K861960 — ZIMLITE LENS (June 9, 1986)

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