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510(k) K843227

MACULAR FUNCTION ANALYZER by Danek Medical, Inc. — Product Code HOQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 1985
Date Received
August 16, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Grid, Amsler
Device Class
Class I
Regulation Number
886.1330
Review Panel
OP
Submission Type

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  • K982875 — MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM (January 19, 1999)
  • K984522 — MODIFICATION OF TSRH SPINAL SYSTEM (January 6, 1999)
  • K982154 — MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM (July 13, 1998)
  • K970599 — TOWNLEY PEDICLE SCREW PLATING SYSTEM (March 20, 1998)
  • K943827 — SPINE FIXATION (February 14, 1996)

Other clearances for product code HOQ

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  • K014044 — MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT) (March 4, 2002)
  • K874252 — KREDA DISC (January 27, 1988)
  • K863429 — MODIFIED DEVICE FOR SELF EXAMINATION OF EYES (January 20, 1987)
  • K843702 — APPARATUS & METHODS SELF-EXAM OF EYE (January 3, 1985)