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510(k) K832997

EPA AUTOMATED INFUSION POLE by Miami Eye Technology, Inc. — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1983
Date Received
September 2, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Phacofragmentation
Device Class
Class II
Regulation Number
886.4670
Review Panel
OP
Submission Type

Other clearances by Miami Eye Technology, Inc.

  • K841101 — CLAYMAN-PAREL CAPSULE COUPEUR (May 16, 1984)
  • K832912 — GELENDER VACUUM FIXATION RING SYS (January 10, 1984)
  • K832996 — SURGICAL IOP MONITOR (November 28, 1983)
  • K832911 — ABBOTT GLOBE HOLDER (September 29, 1983)
  • K831702 — RARE-EARTH INTRA-OCULAR MAGNET (June 30, 1983)

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