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510(k) K915062

DOHLMAN DOANE KERATOPROTHESIS by Mackeen Consultants, Ltd. — Product Code HQM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 1992
Date Received
November 8, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Keratoprosthesis, Permanent Implant
Device Class
Class II
Regulation Number
886.3400
Review Panel
OP
Submission Type

Other clearances by Mackeen Consultants, Ltd.

  • K852737 — LACTOPLATE (October 25, 1985)

Other clearances for product code HQM

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  • K121203 — BOSTON KERATOPROSTHESIS OR BOSTON KPRO (May 10, 2013)
  • K013756 — ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC E (August 29, 2002)