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510(k) K973146

MENTOR SUPER ABSORBENT DRAPE by Mentor Ophthalmics, Inc. — Product Code KKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1997
Date Received
August 22, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drape, Surgical
Device Class
Class II
Regulation Number
878.4370
Review Panel
HO
Submission Type

Other clearances by Mentor Ophthalmics, Inc.

  • K971538 — MENTOR GEMINI HEMOSTATIC ERASER (July 14, 1997)
  • K964312 — MENTOR TONO-PEN 3 (November 26, 1996)
  • K960765 — MENTOR ADVENT A/B SYSTEM (August 8, 1996)

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