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510(k) K852126

ATF 101 TRAIL FRAME by Ascon Medical Instruments, Ltd. — Product Code HPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 1985
Date Received
May 15, 1985
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 by Ascon Medical Instruments, Ltd.

  • K852054 — CONTACT LENS LOUPE, INSPETION LOUPE (September 5, 1985)
  • K852055 — ASCON OPHTHALMIC SPONGE (September 4, 1985)
  • K852548 — ATL 225 MW TRAIL LENS SET (July 31, 1985)
  • K852057 — ASCON SURGICAL INSTRUMENTS (June 27, 1985)
  • K852056 — ACC CROSS CYLINDERS (June 5, 1985)

Other clearances for product code HPA

  • K852548 — ATL 225 MW TRAIL LENS SET (July 31, 1985)
  • K841768 — WOODLYN LIGHTWEIGHT TRIAL FRAME (June 1, 1984)
  • K833669 — IMAGE DEFLECTOR (March 27, 1984)
  • K821084 — UNIVERSAL TRIAL FRAMEE (June 14, 1982)