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510(k) K833669

IMAGE DEFLECTOR by Michael Onufryk — Product Code HPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 1984
Date Received
October 18, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Frame, Trial, Ophthalmic
Device Class
Class I
Regulation Number
886.1415
Review Panel
OP
Submission Type

Other clearances for product code HPA

  • K852548 — ATL 225 MW TRAIL LENS SET (July 31, 1985)
  • K852126 — ATF 101 TRAIL FRAME (June 5, 1985)
  • K841768 — WOODLYN LIGHTWEIGHT TRIAL FRAME (June 1, 1984)
  • K821084 — UNIVERSAL TRIAL FRAMEE (June 14, 1982)